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Medroxyprogesterone (Medroxyprogesterone Acetate) - Summary

 
 



BOX WARNING

WARNINGS
CARDIOVASCULAR AND OTHER RISKS

Estrogens with progestins should not be used for the prevention of cardiovascular disease or dementia. (See CLINICAL STUDIES and WARNINGS, Cardiovascular Disorders and Dementia.)

The Women’s Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo. (See CLINICAL STUDIES and WARNINGS, Cardiovascular Disorders and Malignant Neoplasms, Breast Cancer.)

The Women’s Health Initiative Memory Study (WHIMS), a substudy of the WHI study, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE 0.625 mg combined with MPA 2.5 mg, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. (See CLINICAL STUDIES and WARNINGS, Dementia, and PRECAUTIONS, Geriatric Use.)

In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA and other combinations and dosage forms of estrogens and progestins. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

 

SUMMARY

ADVERSE REACTIONS

Medroxyprogesterone Acetate Tablets contain medroxyprogesterone acetate, which is a derivative of progesterone. It is a white to off-white, odorless, crystalline powder, stable in air, melting between 200 and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water.

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


See all Medroxyprogesterone indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Medroxyprogesterone

Differential effects of estrogen and micronized progesterone or medroxyprogesterone acetate on cognition in postmenopausal women. [2011.08]
OBJECTIVE: To investigate possible differential effects of the coadministration of conjugated equine estrogen (CEE) and a placebo (CEE + PL), CEE and medroxyprogesterone acetate (CEE + MPA), or CEE and micronized P (CEE + MP) on aspects of cognitive functioning in naturally postmenopausal women...

Effects of percutaneous estradiol-oral progesterone versus oral conjugated equine estrogens-medroxyprogesterone acetate on breast cell proliferation and bcl-2 protein in healthy women. [2011.03.01]
In a prospective, randomized clinical study 77 women were assigned randomly to receive sequential hormone therapy with either conventional oral conjugated equine estrogens (0.625 mg) with the addition on 14 of the 28 days of oral medroxyprogesterone acetate (5 mg) or natural E(2) gel (1.5 mg) with oral micronized P (200 mg) on 14 of the 28 days of each cycle.

Differential effects of estrogen and micronized progesterone or medroxyprogesterone acetate on cognition in postmenopausal women. [2011]
OBJECTIVE: To investigate possible differential effects of the coadministration of conjugated equine estrogen (CEE) and a placebo (CEE + PL), CEE and medroxyprogesterone acetate (CEE + MPA), or CEE and micronized P (CEE + MP) on aspects of cognitive functioning in naturally postmenopausal women... These findings need to be replicated with a larger sample size before their potential clinical implications can be determined.

Levonorgestrel-releasing intrauterine system or medroxyprogesterone for heavy menstrual bleeding: a randomized controlled trial. [2010.09]
OBJECTIVE: To compare the efficacy and safety of the levonorgestrel-releasing intrauterine system and oral medroxyprogesterone acetate in the treatment of idiopathic heavy menstrual bleeding... CONCLUSION: In women with idiopathic heavy menstrual bleeding, the levonorgestrel-releasing intrauterine system reduces menstrual blood loss more effectively and has a higher likelihood of treatment success than oral medroxyprogesterone acetate. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00360490. LEVEL OF EVIDENCE: I.

Pharmacist-administered subcutaneous depot medroxyprogesterone acetate: a pilot randomized controlled trial. [2010.08]
BACKGROUND: The objectives of this study were to assess the feasibility of administering subcutaneous depot medroxyprogesterone acetate (DMPA-SC) in a pharmacy setting and assess patient satisfaction... CONCLUSION: Administration of DMPA-SC by pharmacists in a pharmacy setting is feasible. Continuation rates and patient satisfaction with DMPA-SC and the pharmacy setting were comparable to those who received DMPA-SC in a family planning clinic. Copyright 2010 Elsevier Inc. All rights reserved.

more studies >>

Clinical Trials Related to Medroxyprogesterone

Depo-Medroxyprogesterone Acetate (DMPA, Depo-Provera) Use With Certain Anti-HIV Drugs in HIV-Infected Women [Completed]
The purpose of this study is to look at the level of depo-medroxyprogesterone acetate (DMPA or Depo-Provera) in the blood to see if is affected by certain anti-HIV drugs (nelfinavir [NFV], efavirenz [EFV], indinavir [IDV] in combination with ritonavir [RTV], and nevirapine [NVP]). This study will also look at the levels of these anti-HIV drugs to see if they are affected by DMPA.

DMPA is a hormonal birth control method that is given as an injection. It is not known if taking DMPA together with anti-HIV drugs changes the amount of DMPA and/or the amount of anti-HIV drugs in the blood. If higher levels of DMPA occur, side effects may increase. If lower levels of anti-HIV drugs occur, the drugs may become less effective against HIV. This study will look at the levels of anti-HIV drugs and DMPA in the blood when these medications are used together.

Self Administration of Subcutaneous Depot Medroxyprogesterone Acetate [Not yet recruiting]
The purpose of this study is to assess continuation rates and patient satisfaction with self administration subcutaneous depot medroxyprogesterone acetate.

Surgery Plus Medroxyprogesterone in Preventing Endometrial Cancer [Active, not recruiting]
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of surgery with or without medroxyprogesterone may be an effective way to prevent the development of endometrial cancer in patients who have endometrial hyperplasia.

PURPOSE: Phase II trial to compare the effectiveness of surgery alone with that of medroxyprogesterone followed by surgery in preventing endometrial cancer in patients who have endometrial hyperplasia.

Study of a Progestin to Prevent Bleeding Associated With Initiation of Medical Menopause With GnRH Agonist [Recruiting]
In this study, the investigators would like to see if giving medroxyprogesterone acetate for 3 weeks after Leuprolide acetate injection will help to decrease this amount of bleeding, decrease the amount of nausea, bloating and cramping and increase patient satisfaction

Drug Exposure and Depot Medroxyprogesterone Acetate (DMPA) in Adolescent Subjects [Recruiting]
The investigators are doing this study to look at how different doses of the Depot medroxyprogesterone acetate (DMPA) shot effect weight gain and bone mineral density in teens. The investigators hope that what the investigators learn from this study will be used to develop ways to keep girls from gaining weight or losing bone density when receiving DMPA.

more trials >>

Reports of Suspected Medroxyprogesterone Side Effects

Depression (8)Nausea (8)Breast Cancer (7)Dizziness (6)Irritability (6)Agitation (5)Disorientation (5)Somnolence (5)DRY Mouth (5)Nervousness (5)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 1 ratings/reviews, Medroxyprogesterone has an overall score of 6. The effectiveness score is 8 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
 

Medroxyprogesterone review by 54 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   heavy periods, thickened endometrium
Dosage & duration:   10mg daily days 15-27 of my cycle taken daily for the period of 18 months
Other conditions:   hypothyroidism
Other drugs taken:   levothyroxine
  
Reported Results
Benefits:   Periods were not so heavy
Side effects:   constipation, low grade upset stomach
Comments:   daily dose of medication on days 15-27 of my cycle. Periods were not as heavy but I did have breakthrough bleeding mid cycle which would last some months 7 days meaning I would flow for about 14 out of evey 27 days. Doctors could not give an explaination. Am currently on natural progesterone in vaginal cream form - 1gm nightly days 10-15. This is my first month so it's too early to evaluate. I switched becasue I did not want to continue with the oral - I have concerns about long term side effects.

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Page last updated: 2013-02-10

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