U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

Details

Stereochemistry ABSOLUTE
Molecular Formula C24H34O4
Molecular Weight 386.5244
Optical Activity UNSPECIFIED
Defined Stereocenters 7 / 7
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of MEDROXYPROGESTERONE ACETATE

SMILES

[H][C@@]12CC[C@](OC(C)=O)(C(C)=O)[C@@]1(C)CC[C@@]3([H])[C@@]2([H])C[C@H](C)C4=CC(=O)CC[C@]34C

InChI

InChIKey=PSGAAPLEWMOORI-PEINSRQWSA-N
InChI=1S/C24H34O4/c1-14-12-18-19(22(4)9-6-17(27)13-21(14)22)7-10-23(5)20(18)8-11-24(23,15(2)25)28-16(3)26/h13-14,18-20H,6-12H2,1-5H3/t14-,18+,19-,20-,22+,23-,24-/m0/s1

HIDE SMILES / InChI

Molecular Formula C24H34O4
Molecular Weight 386.5244
Charge 0
Count
Stereochemistry ABSOLUTE
Additional Stereochemistry No
Defined Stereocenters 7 / 7
E/Z Centers 0
Optical Activity UNSPECIFIED

Medroxyprogesterone acetate (INN, USAN, BAN), also known as 17α-hydroxy-6α-methylprogesterone acetate, and commonly abbreviated as MPA, is a steroidal progestin, a synthetic variant of the human hormone progesterone. Medroxyprogesterone acetate (MPA) administered orally or parenterally in the recommended doses to women with adequate endogenous estrogen, transforms proliferative into secretory endometrium. Androgenic and anabolic effects have been noted, but the drug is apparently devoid of significant estrogenic activity. While parenterally administered MPA inhibits gonadotropin production, which in turn prevents follicular maturation and ovulation, available data indicate that this does not occur when the usually recommended oral dosage is given as single daily doses. MPA is a more potent derivative of its parent compound medroxyprogesterone (MP). While medroxyprogesterone is sometimes used as a synonym for medroxyprogesterone acetate, what is normally being administered is MPA and not MP. Used as a contraceptive and to treat secondary amenorrhea, abnormal uterine bleeding, pain associated with endometriosis, endometrial and renal cell carcinomas, paraphilia in males, GnRH-dependent forms of precocious puberty, as well as to prevent endometrial changes associated with estrogens. Progestins diffuse freely into target cells in the female reproductive tract, mammary gland, hypothalamus, and the pituitary and bind to the progesterone receptor. Once bound to the receptor, progestins slow the frequency of release of gonadotropin releasing hormone (GnRH) from the hypothalamus and blunt the pre-ovulatory LH surge.

Originator

Approval Year

Targets

Targets

Primary TargetPharmacologyConditionPotency
Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
PROVERA

Approved Use

Medroxyprogesterone Acetate Tablets USP are a progestin indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. Medroxyprogesterone Acetate Tablets USP are also indicated to reduce the incidence of endometrial hyperplasia in nonhysterectomized postmenopausal women receiving daily oral conjugated estrogens 0.625 mg tablets.

Launch Date

1959
Primary
PROVERA

Approved Use

Medroxyprogesterone Acetate Tablets USP are a progestin indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. Medroxyprogesterone Acetate Tablets USP are also indicated to reduce the incidence of endometrial hyperplasia in nonhysterectomized postmenopausal women receiving daily oral conjugated estrogens 0.625 mg tablets.

Launch Date

1959
Preventing
PROVERA

Approved Use

Medroxyprogesterone Acetate Tablets USP are a progestin indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. Medroxyprogesterone Acetate Tablets USP are also indicated to reduce the incidence of endometrial hyperplasia in nonhysterectomized postmenopausal women receiving daily oral conjugated estrogens 0.625 mg tablets.

Launch Date

1959
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
0.71 ng/mL
10 mg 1 times / day steady-state, oral
dose: 10 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
MEDROXYPROGESTERONE ACETATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE
food status: FASTED
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
6.01 ng × h/mL
10 mg 1 times / day steady-state, oral
dose: 10 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
MEDROXYPROGESTERONE ACETATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE
food status: FASTED
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
16.6 h
10 mg 1 times / day steady-state, oral
dose: 10 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
MEDROXYPROGESTERONE ACETATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE
food status: FASTED
Funbound

Funbound

ValueDoseCo-administeredAnalytePopulation
10%
10 mg 1 times / day steady-state, oral
dose: 10 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
MEDROXYPROGESTERONE ACETATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE
food status: FASTED
Doses

Doses

DosePopulationAdverse events​
150 mg 3 times / month multiple, intramuscular
Recommended
Dose: 150 mg, 3 times / month
Route: intramuscular
Route: multiple
Dose: 150 mg, 3 times / month
Sources: Page: p.7
healthy, 15 - 51
n = 3900
Health Status: healthy
Condition: Prevention of pregnancy
Age Group: 15 - 51
Sex: F
Population Size: 3900
Sources: Page: p.7
Disc. AE: Bleeding, Amenorrhea...
AEs leading to
discontinuation/dose reduction:
Bleeding (8.2%)
Amenorrhea (2.1%)
Weight gain (2%)
Sources: Page: p.7
20 mg 1 times / day multiple, oral
Highest studied dose
Dose: 20 mg, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg, 1 times / day
Co-administed with::
E2V, p.o(2 mg; q.d)
Sources: Page: p.12
healthy, 45-66
n = 132
Health Status: healthy
Condition: Postmenopause
Age Group: 45-66
Sex: F
Population Size: 132
Sources: Page: p.12
Disc. AE: Bleeding, Uterine fibroids...
AEs leading to
discontinuation/dose reduction:
Bleeding (3.8%)
Uterine fibroids (2.3%)
Gallstones (0.76%)
Endometrial polyp (0.76%)
Sources: Page: p.12
2.5 mg 1 times / day multiple, oral
Studied dose
Dose: 2.5 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2.5 mg, 1 times / day
Co-administed with::
conjugated estrogens, p.o(0.625 mg; q.d)
Sources: Page: p.1325
healthy, 45-79
n = 284
Health Status: healthy
Condition: Postmenopause
Age Group: 45-79
Sex: F
Population Size: 284
Sources: Page: p.1325
Disc. AE: Bleeding vaginal...
AEs leading to
discontinuation/dose reduction:
Bleeding vaginal (9%)
Sources: Page: p.1325
10 mg 1 times / day multiple, oral (max)
Recommended
Dose: 10 mg, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg, 1 times / day
Co-administed with::
conjugated estrogens, p.o(0.625 mg; q.d)
Sources: Page: p.1, p.5
healthy, 50 -79
n = 8506
Health Status: healthy
Condition: Postmenopause
Age Group: 50 -79
Sex: F
Population Size: 8506
Sources: Page: p.1, p.5
Disc. AE: Myocardial infarction, Stroke...
AEs leading to
discontinuation/dose reduction:
Myocardial infarction
Stroke
Breast cancer invasive NOS
Embolism pulmonary
Deep vein thrombosis
Sources: Page: p.1, p.5
10 mg 1 times / day multiple, oral
Recommended
Dose: 10 mg, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg, 1 times / day
Sources: Page: p.628
unhealthy, >18
n = 83
Health Status: unhealthy
Condition: Idiopathic heavy menstrual bleeding
Age Group: >18
Sex: F
Population Size: 83
Sources: Page: p.628
Disc. AE: Dizziness, Fluid retention...
AEs leading to
discontinuation/dose reduction:
Dizziness (1.2%)
Fluid retention (1.2%)
Sources: Page: p.628
2.5 mg 1 times / day multiple, oral
Studied dose
Dose: 2.5 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2.5 mg, 1 times / day
Co-administed with::
conjugated estrogens, p.o(0.625 mg; q.d)
Sources: Page: p.1, p.5
healthy, >65
Health Status: healthy
Condition: Postmenopause
Age Group: >65
Sex: F
Sources: Page: p.1, p.5
Disc. AE: Dementia...
AEs leading to
discontinuation/dose reduction:
Dementia
Sources: Page: p.1, p.5
10 mg 1 times / day multiple, oral (max)
Recommended
Dose: 10 mg, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg, 1 times / day
Sources: Page: p.1
unhealthy
Health Status: unhealthy
Condition: Secondary Amenorrhea|Abnormal Uterine Bleeding Due to Hormonal Imbalance
Sex: F
Sources: Page: p.1
Disc. AE: Cardiovascular disorder...
AEs leading to
discontinuation/dose reduction:
Cardiovascular disorder
Sources: Page: p.1
150 mg 3 times / month multiple, intramuscular
Recommended
Dose: 150 mg, 3 times / month
Route: intramuscular
Route: multiple
Dose: 150 mg, 3 times / month
Sources: Page: p.1
healthy
Health Status: healthy
Condition: Prevention of pregnancy
Sex: F
Sources: Page: p.1
Disc. AE: Bone density abnormal...
AEs leading to
discontinuation/dose reduction:
Bone density abnormal
Sources: Page: p.1
AEs

AEs

AESignificanceDosePopulation
Weight gain 2%
Disc. AE
150 mg 3 times / month multiple, intramuscular
Recommended
Dose: 150 mg, 3 times / month
Route: intramuscular
Route: multiple
Dose: 150 mg, 3 times / month
Sources: Page: p.7
healthy, 15 - 51
n = 3900
Health Status: healthy
Condition: Prevention of pregnancy
Age Group: 15 - 51
Sex: F
Population Size: 3900
Sources: Page: p.7
Amenorrhea 2.1%
Disc. AE
150 mg 3 times / month multiple, intramuscular
Recommended
Dose: 150 mg, 3 times / month
Route: intramuscular
Route: multiple
Dose: 150 mg, 3 times / month
Sources: Page: p.7
healthy, 15 - 51
n = 3900
Health Status: healthy
Condition: Prevention of pregnancy
Age Group: 15 - 51
Sex: F
Population Size: 3900
Sources: Page: p.7
Bleeding 8.2%
Disc. AE
150 mg 3 times / month multiple, intramuscular
Recommended
Dose: 150 mg, 3 times / month
Route: intramuscular
Route: multiple
Dose: 150 mg, 3 times / month
Sources: Page: p.7
healthy, 15 - 51
n = 3900
Health Status: healthy
Condition: Prevention of pregnancy
Age Group: 15 - 51
Sex: F
Population Size: 3900
Sources: Page: p.7
Endometrial polyp 0.76%
Disc. AE
20 mg 1 times / day multiple, oral
Highest studied dose
Dose: 20 mg, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg, 1 times / day
Co-administed with::
E2V, p.o(2 mg; q.d)
Sources: Page: p.12
healthy, 45-66
n = 132
Health Status: healthy
Condition: Postmenopause
Age Group: 45-66
Sex: F
Population Size: 132
Sources: Page: p.12
Gallstones 0.76%
Disc. AE
20 mg 1 times / day multiple, oral
Highest studied dose
Dose: 20 mg, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg, 1 times / day
Co-administed with::
E2V, p.o(2 mg; q.d)
Sources: Page: p.12
healthy, 45-66
n = 132
Health Status: healthy
Condition: Postmenopause
Age Group: 45-66
Sex: F
Population Size: 132
Sources: Page: p.12
Uterine fibroids 2.3%
Disc. AE
20 mg 1 times / day multiple, oral
Highest studied dose
Dose: 20 mg, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg, 1 times / day
Co-administed with::
E2V, p.o(2 mg; q.d)
Sources: Page: p.12
healthy, 45-66
n = 132
Health Status: healthy
Condition: Postmenopause
Age Group: 45-66
Sex: F
Population Size: 132
Sources: Page: p.12
Bleeding 3.8%
Disc. AE
20 mg 1 times / day multiple, oral
Highest studied dose
Dose: 20 mg, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg, 1 times / day
Co-administed with::
E2V, p.o(2 mg; q.d)
Sources: Page: p.12
healthy, 45-66
n = 132
Health Status: healthy
Condition: Postmenopause
Age Group: 45-66
Sex: F
Population Size: 132
Sources: Page: p.12
Bleeding vaginal 9%
Disc. AE
2.5 mg 1 times / day multiple, oral
Studied dose
Dose: 2.5 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2.5 mg, 1 times / day
Co-administed with::
conjugated estrogens, p.o(0.625 mg; q.d)
Sources: Page: p.1325
healthy, 45-79
n = 284
Health Status: healthy
Condition: Postmenopause
Age Group: 45-79
Sex: F
Population Size: 284
Sources: Page: p.1325
Breast cancer invasive NOS Disc. AE
10 mg 1 times / day multiple, oral (max)
Recommended
Dose: 10 mg, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg, 1 times / day
Co-administed with::
conjugated estrogens, p.o(0.625 mg; q.d)
Sources: Page: p.1, p.5
healthy, 50 -79
n = 8506
Health Status: healthy
Condition: Postmenopause
Age Group: 50 -79
Sex: F
Population Size: 8506
Sources: Page: p.1, p.5
Deep vein thrombosis Disc. AE
10 mg 1 times / day multiple, oral (max)
Recommended
Dose: 10 mg, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg, 1 times / day
Co-administed with::
conjugated estrogens, p.o(0.625 mg; q.d)
Sources: Page: p.1, p.5
healthy, 50 -79
n = 8506
Health Status: healthy
Condition: Postmenopause
Age Group: 50 -79
Sex: F
Population Size: 8506
Sources: Page: p.1, p.5
Embolism pulmonary Disc. AE
10 mg 1 times / day multiple, oral (max)
Recommended
Dose: 10 mg, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg, 1 times / day
Co-administed with::
conjugated estrogens, p.o(0.625 mg; q.d)
Sources: Page: p.1, p.5
healthy, 50 -79
n = 8506
Health Status: healthy
Condition: Postmenopause
Age Group: 50 -79
Sex: F
Population Size: 8506
Sources: Page: p.1, p.5
Myocardial infarction Disc. AE
10 mg 1 times / day multiple, oral (max)
Recommended
Dose: 10 mg, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg, 1 times / day
Co-administed with::
conjugated estrogens, p.o(0.625 mg; q.d)
Sources: Page: p.1, p.5
healthy, 50 -79
n = 8506
Health Status: healthy
Condition: Postmenopause
Age Group: 50 -79
Sex: F
Population Size: 8506
Sources: Page: p.1, p.5
Stroke Disc. AE
10 mg 1 times / day multiple, oral (max)
Recommended
Dose: 10 mg, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg, 1 times / day
Co-administed with::
conjugated estrogens, p.o(0.625 mg; q.d)
Sources: Page: p.1, p.5
healthy, 50 -79
n = 8506
Health Status: healthy
Condition: Postmenopause
Age Group: 50 -79
Sex: F
Population Size: 8506
Sources: Page: p.1, p.5
Dizziness 1.2%
Disc. AE
10 mg 1 times / day multiple, oral
Recommended
Dose: 10 mg, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg, 1 times / day
Sources: Page: p.628
unhealthy, >18
n = 83
Health Status: unhealthy
Condition: Idiopathic heavy menstrual bleeding
Age Group: >18
Sex: F
Population Size: 83
Sources: Page: p.628
Fluid retention 1.2%
Disc. AE
10 mg 1 times / day multiple, oral
Recommended
Dose: 10 mg, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg, 1 times / day
Sources: Page: p.628
unhealthy, >18
n = 83
Health Status: unhealthy
Condition: Idiopathic heavy menstrual bleeding
Age Group: >18
Sex: F
Population Size: 83
Sources: Page: p.628
Dementia Disc. AE
2.5 mg 1 times / day multiple, oral
Studied dose
Dose: 2.5 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2.5 mg, 1 times / day
Co-administed with::
conjugated estrogens, p.o(0.625 mg; q.d)
Sources: Page: p.1, p.5
healthy, >65
Health Status: healthy
Condition: Postmenopause
Age Group: >65
Sex: F
Sources: Page: p.1, p.5
Cardiovascular disorder Disc. AE
10 mg 1 times / day multiple, oral (max)
Recommended
Dose: 10 mg, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg, 1 times / day
Sources: Page: p.1
unhealthy
Health Status: unhealthy
Condition: Secondary Amenorrhea|Abnormal Uterine Bleeding Due to Hormonal Imbalance
Sex: F
Sources: Page: p.1
Bone density abnormal Disc. AE
150 mg 3 times / month multiple, intramuscular
Recommended
Dose: 150 mg, 3 times / month
Route: intramuscular
Route: multiple
Dose: 150 mg, 3 times / month
Sources: Page: p.1
healthy
Health Status: healthy
Condition: Prevention of pregnancy
Sex: F
Sources: Page: p.1
OverviewDrug as perpetrator​Drug as victim

Drug as victim

TargetModalityActivityMetaboliteClinical evidence
no
no
no
no
no
no
no
no
no
no
no
yes
likely (co-administration study)
Comment: Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of contraceptive drug products.
PubMed

PubMed

TitleDatePubMed
[Pulmonary lymphangioleiomyomatosis: presentation and results of treatment].
2001
Organ preserving method in the management of atypical endometrial hyperplasia.
2001
Quantitative evaluation of collagen and muscle fibers in the lower urinary tract of castrated and under-hormone replacement female rats.
2001
Effect of medroxyprogesterone pretreatment on pentagastrin-induced panic symptoms in females with panic disorder.
2001 Apr 15
Effects of hormone replacement therapy on cognitive performance in elderly women.
2001 Apr 20
[A case of pulmonary lymphangioleiomyomatosis originally treated as bronchial asthma].
2001 Aug
Rat uterine complement C3 expression as a model for progesterone receptor modulators: characterization of the new progestin trimegestone.
2001 Aug
Effects of hormone replacement therapy on endocrine and spirometric parameters in asthmatic postmenopausal women.
2001 Aug
Thoracic endometriosis syndrome resembling pulmonary embolism.
2001 Aug
Bone marrow failure from medication error: diagnosis by history, not biopsy.
2001 Aug 13-27
Transdermal hormone replacement therapy in postmenopausal women with uterine leiomyomas.
2001 Dec
Urinary tract infections in postmenopausal women: effect of hormone therapy and risk factors.
2001 Dec
Hormone replacement therapy and endothelial function: the exception that proves the rule?
2001 Dec
Hormone replacement therapy and endothelial function. Results of a randomized controlled trial in healthy postmenopausal women.
2001 Dec
How to use progestin in hormone replacement therapy: an animal experiment.
2001 Feb
Estrogen improves impaired musculocutaneous vascular adrenergic reactivity in pharmacologically ovariectomized rats: a potential peripheral mechanism for hot flashes?
2001 Feb
[Advanced breast cancer with multiple bone metastases successfully treated with combined chemoendocrine-therapy of CEF (cyclophosphamide, epirubicin, 5-fluorouracil) and 5'-DFUR (5'-deoxy-5-fluorouridine) + MPA (medroxyprogesterone acetate)--a case report].
2001 Feb
Monthly injection provides new contraceptive choice.
2001 Jan-Feb
Hormonal and barrier contraception and risk of upper genital tract disease in the PID Evaluation and Clinical Health (PEACH) study.
2001 Jul
Changes in quality of life after hormonal treatment of endometriosis.
2001 Jul
Diabetes and depot medroxyprogesterone contraception in Navajo women.
2001 Jul 23
Lunelle: a new contraceptive alternative.
2001 Jun
The incidence of unrecognized myocardial infarction in women with coronary heart disease.
2001 Jun 5
Increased need for thyroxine in women with hypothyroidism during estrogen therapy.
2001 Jun 7
Hormone replacement therapy in healthy postmenopausal women: a randomized, placebo-controlled study of effects on coagulation and fibrinolytic factors.
2001 Mar
[Endometriosis of the abdominal wall: diagnosis and treatment techniques].
2001 May
Dose response effect of cyclical medroxyprogesterone on blood pressure in postmenopausal women.
2001 May
Observer variation--how many observers for generalizability?
2001 May
Quinacrine non-surgical female sterilization in Bangladesh.
2001 Nov
Acute and mid-term combined hormone replacement therapy improves endothelial function in post-menopausal women with angina and angiographically normal coronary arteries.
2001 Nov
Anaylsis of birefringence during wound healing and remodeling following alkali burns in rabbit cornea.
2001 Oct
Interactions between antiepileptic drugs and hormonal contraception.
2002
Use of medroxyprogesterone acetate in the treatment of Müllerian adenosarcoma: a case report.
2002 Apr
Contraceptive efficacy and patient acceptance of Lunelle.
2002 Aug
Effects of tibolone and continuous combined hormone replacement therapy on bleeding rates, quality of life and tolerability in postmenopausal women.
2002 Aug
High-risk teen compliance with prescription contraception: an analysis of Ohio Medicaid claims.
2002 Feb
Intrauterine 10 microg and 20 microg levonorgestrel systems in postmenopausal women receiving oral oestrogen replacement therapy: clinical, endometrial and metabolic response.
2002 Feb
Effects of hormonal replacement therapy on oxidative stress and total antioxidant capacity in postmenopausal hemodialysis patients.
2002 Jan
Effects of acute hormone therapy on recurrent ischemia in postmenopausal women with unstable angina.
2002 Jan 16
HRT: forever or never?
2002 Jul-Aug
Medroxyprogesterone-induced endocrine alterations after menopause.
2002 Jul-Aug
Estrogen status correlates with the calcium content of coronary atherosclerotic plaques in women.
2002 Mar
Pharmacological characterization of the ATP-dependent low K(m) guanosine 3',5'-cyclic monophosphate (cGMP) transporter in human erythrocytes.
2002 Mar 1
Effect of postmenopausal hormone therapy on cardiovascular risk.
2002 May
Hormone replacement therapy: estrogen and progestin effects on plasma C-reactive protein concentrations.
2002 May
Effect of medroxyprogesterone on pulmonary arterial pressure, exhaled nitric oxide, ECG and arterial blood gases.
2002 May
Contraceptive applications of estrogen.
2002 May-Jun
Influence of estradiol and gestagens on oxidative stress in the rat uterus.
2002 Sep
Chronic respiratory failure: an unusual cause and treatment.
2002 Sep
Effect of hormone replacement therapy on uterine fibroids in postmenopausal women--a 3-year study.
2002 Sep 30
Patents

Patents

Sample Use Guides

Secondary Amenorrhea: PROVERA (medroxyprogesterone acetate ) tablets may be given in dosages of 5 or 10 mg daily for 5 to 10 days. Abnormal Uterine Bleeding Due to Hormonal Imbalance in the Absence of Organic Pathology: Beginning on the calculated 16th or 21st day of the menstrual cycle, 5 or 10 mg of PROVERA may be given daily for 5 to 10 days. Reduction of Endometrial Hyperplasia in Postmenopausal Women: Receiving Daily 0.625 mg Conjugated Estrogens
Route of Administration: Oral
Freshly isolated PBMCs (peripheral blood mononuclear cells) from normal blood donors were treated with physiologic MPA (medroxyprogesterone acetate) concentrations ranging from 0.003 to 5 ng/ml and infected with GFP-tagged R5-tropic or X4-tropic HIV-1 pseudoviruses by spinoculation. The infection was limited to a single cycle. Cells were stained with CD3, CD8 and CD14
Substance Class Chemical
Created
by admin
on Fri Dec 15 15:00:43 GMT 2023
Edited
by admin
on Fri Dec 15 15:00:43 GMT 2023
Record UNII
C2QI4IOI2G
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
MEDROXYPROGESTERONE ACETATE
EP   JAN   MART.   ORANGE BOOK   USP   USP-RS   VANDF   WHO-DD   WHO-IP  
Common Name English
DEPOT-MEDROXYPROGESTERONE ACETATE
Common Name English
17-Hydroxy-6α-methylpregn-4-ene-3,20-dione acetate
Common Name English
PREGN-4-ENE-3,20-DIONE, 17-(ACETYLOXY)-6-METHYL-, (6.ALPHA.)-
Systematic Name English
MEDROXYPROGESTERONE 17-ACETATE
MI  
Common Name English
MEDROXYPROGESTERONE ACETATE [USP MONOGRAPH]
Common Name English
AMEN
Brand Name English
CURRETAB
Brand Name English
MEDROXYPROGESTERONE ACETATE [WHO-IP]
Common Name English
MEGESTROL ACETATE IMPURITY A [EP IMPURITY]
Common Name English
MEDROXYPROGESTERONE ACETATE [MART.]
Common Name English
MEDROXYPROGESTERONE ACETATE [ORANGE BOOK]
Common Name English
DEPO-SUBQ PROVERA 104
Brand Name English
MEDROXYPROGESTERONE ACETATE [IARC]
Common Name English
MEDROXYPROGESTERONE ACETATE COMPONENT OF LUNELLE
Common Name English
MEDROXYPROGESTERONE 17-ACETATE [MI]
Common Name English
TV-46046
Code English
PREMPHASE COMPONENT MEDROXYPROGESTERONE ACETATE
Brand Name English
MEDROXYPROGESTERONE ACETATE COMPONENT OF PREMPHASE
Brand Name English
NSC-21171
Code English
DMPA
Common Name English
PROVERA
Brand Name English
MEDROXYPROGESTERONE ACETATE [VANDF]
Common Name English
MEDROXYPROGESTERONI ACETAS [WHO-IP LATIN]
Common Name English
LUNELLE COMPONENT MEDROXYPROGESTERONE ACETATE
Common Name English
MEDROXYPROGESTERONE ACETATE [USP-RS]
Common Name English
NSC-26386
Code English
MEDROXYPROGESTERONE ACETATE [JAN]
Common Name English
MEDROXYPROGESTERONE ACETATE [EP MONOGRAPH]
Common Name English
CYCRIN
Brand Name English
PREMPRO COMPONENT MEDROXYPROGESTERONE ACETATE
Brand Name English
DEPO-PROVERA
Brand Name English
MEDROXYPROGESTERONE ACETATE COMPONENT OF PREMPRO
Brand Name English
Medroxyprogesterone acetate [WHO-DD]
Common Name English
Classification Tree Code System Code
FDA ORPHAN DRUG 141901
Created by admin on Fri Dec 15 15:00:43 GMT 2023 , Edited by admin on Fri Dec 15 15:00:43 GMT 2023
IARC Medroxyprogesterone acetate
WHO-ESSENTIAL MEDICINES LIST 18.3.2
Created by admin on Fri Dec 15 15:00:44 GMT 2023 , Edited by admin on Fri Dec 15 15:00:44 GMT 2023
WHO-ESSENTIAL MEDICINES LIST 18.7
Created by admin on Fri Dec 15 15:00:44 GMT 2023 , Edited by admin on Fri Dec 15 15:00:44 GMT 2023
NCI_THESAURUS C776
Created by admin on Fri Dec 15 15:00:43 GMT 2023 , Edited by admin on Fri Dec 15 15:00:43 GMT 2023
WHO-ESSENTIAL MEDICINES LIST 18.3.2 (EST/MED)
Created by admin on Fri Dec 15 15:00:44 GMT 2023 , Edited by admin on Fri Dec 15 15:00:44 GMT 2023
Code System Code Type Description
NSC
21171
Created by admin on Fri Dec 15 15:00:43 GMT 2023 , Edited by admin on Fri Dec 15 15:00:43 GMT 2023
PRIMARY
WHO INTERNATIONAL PHARMACOPEIA
MEDROXYPROGESTERONE ACETATE
Created by admin on Fri Dec 15 15:00:44 GMT 2023 , Edited by admin on Fri Dec 15 15:00:44 GMT 2023
PRIMARY Description: A white or almost white, crystalline powder. Solubility: Practically insoluble in water; soluble in acetone R and dioxan R; slightly soluble in ethanol (~750 g/L) TS, methanol Rand ether R. Category: Progestogen. Storage: Medroxyprogesterone acetate should be kept in a tight container, protected from light. Definition: Medroxyprogesterone acetate contains not less than 97.0% and not more than the equivalent of 103.0% of C24H34O4,calculated with reference to the dried substance.
RXCUI
1000112
Created by admin on Fri Dec 15 15:00:44 GMT 2023 , Edited by admin on Fri Dec 15 15:00:44 GMT 2023
PRIMARY RxNorm
ALANWOOD
DMPA
Created by admin on Fri Dec 15 15:00:43 GMT 2023 , Edited by admin on Fri Dec 15 15:00:43 GMT 2023
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MESH
D017258
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NSC
26386
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PRIMARY
EVMPD
SUB03114MIG
Created by admin on Fri Dec 15 15:00:43 GMT 2023 , Edited by admin on Fri Dec 15 15:00:43 GMT 2023
PRIMARY
CAS
71-58-9
Created by admin on Fri Dec 15 15:00:43 GMT 2023 , Edited by admin on Fri Dec 15 15:00:43 GMT 2023
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EVMPD
SUB127224
Created by admin on Fri Dec 15 15:00:43 GMT 2023 , Edited by admin on Fri Dec 15 15:00:43 GMT 2023
ALTERNATIVE
FDA UNII
C2QI4IOI2G
Created by admin on Fri Dec 15 15:00:43 GMT 2023 , Edited by admin on Fri Dec 15 15:00:43 GMT 2023
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DAILYMED
C2QI4IOI2G
Created by admin on Fri Dec 15 15:00:43 GMT 2023 , Edited by admin on Fri Dec 15 15:00:43 GMT 2023
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DRUG BANK
DB00603
Created by admin on Fri Dec 15 15:00:43 GMT 2023 , Edited by admin on Fri Dec 15 15:00:43 GMT 2023
PRIMARY
CHEBI
6716
Created by admin on Fri Dec 15 15:00:43 GMT 2023 , Edited by admin on Fri Dec 15 15:00:43 GMT 2023
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NCI_THESAURUS
C1155
Created by admin on Fri Dec 15 15:00:43 GMT 2023 , Edited by admin on Fri Dec 15 15:00:43 GMT 2023
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SMS_ID
100000091612
Created by admin on Fri Dec 15 15:00:44 GMT 2023 , Edited by admin on Fri Dec 15 15:00:44 GMT 2023
PRIMARY
MERCK INDEX
m7134
Created by admin on Fri Dec 15 15:00:43 GMT 2023 , Edited by admin on Fri Dec 15 15:00:43 GMT 2023
PRIMARY Merck Index
WIKIPEDIA
MEDROXYPROGESTERONE ACETATE
Created by admin on Fri Dec 15 15:00:44 GMT 2023 , Edited by admin on Fri Dec 15 15:00:44 GMT 2023
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ECHA (EC/EINECS)
200-757-9
Created by admin on Fri Dec 15 15:00:43 GMT 2023 , Edited by admin on Fri Dec 15 15:00:43 GMT 2023
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RS_ITEM_NUM
1378001
Created by admin on Fri Dec 15 15:00:44 GMT 2023 , Edited by admin on Fri Dec 15 15:00:44 GMT 2023
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ChEMBL
CHEMBL717
Created by admin on Fri Dec 15 15:00:43 GMT 2023 , Edited by admin on Fri Dec 15 15:00:43 GMT 2023
PRIMARY
EPA CompTox
DTXSID0025527
Created by admin on Fri Dec 15 15:00:43 GMT 2023 , Edited by admin on Fri Dec 15 15:00:43 GMT 2023
PRIMARY
PUBCHEM
6279
Created by admin on Fri Dec 15 15:00:44 GMT 2023 , Edited by admin on Fri Dec 15 15:00:44 GMT 2023
PRIMARY
LACTMED
Medroxyprogesterone Acetate
Created by admin on Fri Dec 15 15:00:43 GMT 2023 , Edited by admin on Fri Dec 15 15:00:43 GMT 2023
PRIMARY
Related Record Type Details
BASIS OF STRENGTH->SUBSTANCE
ASSAY (UV)
EP
BASIS OF STRENGTH->SUBSTANCE
ASSAY (HPLC)
USP
Related Record Type Details
IMPURITY -> PARENT
MEDROXYPROGESTERONE ACETATE Impurity E. In the chromatogram obtained with solution (1):the area of any peak corresponding to impurity C, E or I is not greater than 2 times the area of the principal peak obtained with solution (3) (0.2%).
IMPURITY -> PARENT
UNSPECIFIED
EP
IMPURITY -> PARENT
The following peaks are eluted at the following relative retention with reference to the peak of medroxyprogesterone acetate (retention time about 27 minutes): impurity C about 0.8. The test is not valid unless in the chromatogram obtained with solution (4) the resolution factor between the peaks due to impurity G and due to medroxyprogesterone acetate is at least 3.3. In the chromatogram obtained with solution (1):the area of any peak corresponding to impurity C, E or I is not greater than 2 times the area of the principal peak obtained with solution (3) (0.2%).
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
MEDROXYPROGESTERONE ACETATE Impurity I. The following peaks are eluted at the following relative retention with reference to the peak of medroxyprogesterone acetate (retention time about 27 minutes): impurity I about 0.5. In the chromatogram obtained with solution (1):the area of any peak corresponding to impurity C, E or I is not greater than 2 times the area of the principal peak obtained with solution (3) (0.2%).
IMPURITY -> PARENT
For the calculation of contents, multiply the peak areas by 1.5
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
For the calculation of contents, multiply the peak areas by 2.6
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
MEDROXYPROGESTERONE ACETATE Impurity F. Amount not specified.
IMPURITY -> PARENT
MEDROXYPROGESTERONE ACETATE Impurity H. The following peaks are eluted at the following relative retention with reference to the peak of medroxyprogesterone acetate (retention time about 27 minutes): impurity H about 0.65.
IMPURITY -> PARENT
For the calculation of contents, multiply the peak areas by 1.8
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
MEDROXYPROGESTERONE ACETATE Impurity B. In the chromatogram obtained with solution (1):the area of any peak corresponding to impurity B is not greater than 0.7 times the area of the principal peak obtained with solution (2) (0.7%).
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
MEDROXYPROGESTERONE ACETATE Impurity G. In the chromatogram obtained with solution (1):the area of any peak corresponding to impurity G, when multiplied by a correction factor of 2.6, is not greater than 2 times of the area of the principal peak obtained with solution (3) (0.2%).
PARENT -> IMPURITY
For the calculation of contents, multiply the peak areas by 0.2
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
MEDROXYPROGESTERONE ACETATE Impurity D. In the chromatogram obtained with solution (1):the area of any peak corresponding to impurity D is not greater than the area of the principal peak obtained with solution (2) (1.0%).
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
MEDROXYPROGESTERONE ACETATE Impurity A. In the chromatogram obtained with solution (1):the area of any peak corresponding to impurity A, when multiplied by a correction factor of 1.5, is not greater than 3 times of the area of the principal peak obtained with solution (3) (0.3%).
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
Related Record Type Details
ACTIVE MOIETY