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Provera (Medroxyprogesterone Acetate) - Summary

 
 



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.

 

PROVERA SUMMARY

PROVERA 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 210C. 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.

PROVERA 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. PROVERA Tablets are also indicated to reduce the incidence of endometrial hyperplasia in nonhysterectomized postmenopausal women receiving 0.625 mg conjugated estrogen.


See all Provera indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Provera (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.

Vaginal estrogen supplementation during Depo-Provera initiation: a randomized controlled trial. [2010.09]
BACKGROUND: Irregular bleeding is often cited as the reason for discontinuation of depot-medroxyprogesterone acetate (DMPA) after the first injection. Estrogen supplementation during DMPA initiation may decrease bleeding and improve continuation... CONCLUSIONS: Vaginal estrogen supplementation during DMPA initiation is acceptable to women and may decrease total bleeding. Copyright 2010 Elsevier Inc. All rights reserved.

more studies >>

Clinical Trials Related to Provera (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.

Acceptability of Depo-subQ Provera 104 in Uniject vs. Intramuscular Depo-Provera Among HIV+ Women & Providers, Uganda [Not yet recruiting]
The purpose of this study is to assess acceptability and side effects of a low-dose injectable contraceptive formulation which is delivered under the skin (subcutaneously), as compared with injectable contraception delivered into the muscle (intramuscularly) among adult HIV-positive women who attend mobile clinics for HIV care and wish to use injectable contraception. The investigators will also assess experiences experiences delivering these two types of injections among health care providers working within the HIV care clinics.

Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding Continuation, Contraceptive Continuation, and Postpartum Depression [Not yet recruiting]
In the United States, depot medroxyprogesterone acetate (DMPA) is given to women after delivery and before hospital discharge with the belief that women who delay starting DMPA may be more likely to become pregnant when they are not yet ready to be pregnant and that giving DMPA before discharge has little to no negative effect on breastfeeding. Administering DMPA to breastfeeding women has not been widely questioned because the limited existing studies do not show any adverse impact of DMPA on breastfeeding. However, these studies used inappropriate control groups and did not control for prior lactation experience.

The investigators plan to enroll 184 women who are planning to breastfeed and use DMPA after delivery to find out whether the timing of postpartum administration of DMPA (prior to hospital discharge or 4-6 weeks after delivery) affects the duration or exclusivity of breastfeeding among women who plan to breastfeed their infants. The investigators will also look at rates of use of highly effective contraception (defined as DMPA, intrauterine device, implant, sterilization, or lactational amenorrhea) and postpartum depression.

Depo-Provera: Bone Mineral Density and Total Body Calcium in Adolescent DP150CI Users and Non-Hormonal Contraception [Completed]
To evaluate and compare Bone Mineral Density (BMD) in adolescent Depo-Provera Contraceptive Injection (DP150CI) users during depo medroxyprogesterone acetate (DMPA) therapy and following discontinuation of DMPA. Another group electing non-hormonal contraception or abstinence will be recruited as a reference population, across all study sites. The primary variable is BMD, measured by Dual Energy X-ray Absorptiometry (DXA). Secondary variables are: Total Body Composition& Total Body Calcium (TBC), measured by Dual Energy X-ray Absorptiometry (DXA), and surrogate biologic BMD markers. Safety will be evaluated by adverse event reporting, laboratory evaluations, pregnancies, weight and vital signs.

Modulation of Mucosal and Systemic Immunity by Hormonal Contraceptives [Recruiting]
The investigators are conducting a research study to understand how cells responsible for fighting infection (immune cells) are affected by hormonal contraceptive use. The investigators hypothesize that progestin-containing hormonal contraceptives (i. e., Depo-Provera) inhibit host response to infection. To test this hypothesis, the investigators will collect blood and genital tract samples from women before and after their initiation of a hormonal contraceptive (either birth control pills, Depo-Provera, or Mirena).

more trials >>

Reports of Suspected Provera (Medroxyprogesterone) Side Effects

Breast Cancer Female (84)Depression (31)Breast Cancer (31)Breast Cancer Metastatic (23)Anxiety (21)Drug Ineffective (14)Pain in Extremity (12)Breast Mass (9)Insomnia (9)Abdominal Pain (8)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 5 ratings/reviews, Provera has an overall score of 6.40. The effectiveness score is 7.60 and the side effect score is 6.80. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Provera review by 46 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   irregular menses
Dosage & duration:   10 mg taken 12 days/month for the period of 6 months
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   The treatment benefits of taking Provera were very good. I had very irregular menses that lasted for long periods of time. By taking the Provera day 15-26 of my cycle my periods began to normalize and become regular again.
Side effects:   The only side effects I noticed were during the first two days or so of taking Provera I was more tired than usual. I also noticed I felt more bloated than when I was not taking it.
Comments:   On day 15 of my cycle I took the Provera 10 mg for 12 days and then stopped to promote a period. It took a couple of cycles for this to become effective, but utilizing the drug in this manner did take care of the problem of irregular bleeding in between periods.

 

Provera review by 53 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   heavy menses
Dosage & duration:   10 mg taken 1 per day for the period of 4 months
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   It did control my periods. Other benefits included a mild feeling of well being and return to health.
Side effects:   spotting, some mild depression, not unlike PMS symptoms when younger. There was some cramping and some spotting.
Comments:   following an episode of a 2 month long period with episodes of very heavy flow, doctor prescribed the Provera to regulate period until menopause resulted in the cessation of menses.

 

Provera review by 26 year old female patient

  Rating
Overall rating:  
Effectiveness:   Marginally Effective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   hormones
Dosage & duration:   50mg taken 2 times dailey for the period of 3 monts
Other conditions:   none
Other drugs taken:   clomid
  
Reported Results
Benefits:   resume ovulation and maintain hormonal balance
Side effects:   Horrible mood swings, crying episodes, confusion.
Comments:   In order to correct Polycystic ovarian syndrom and to get pregnant I was given Progestin and clomid to resume ovulation. I would NEVER* take either of these synthetics again! I was a basketcase with mood swings, crying, depression etc.. and once I discontinued use I was able to return to a normal mental state. I used this for over 3 months while my poor family suffered, never recieving the results I hoped for. I achieved results only when I went natural and used a natural progetserone cream from AIM made with wild yam and instead of horrific side effects I had pleasant ones...my acne cleared, my insomnia got better and my overall mood was improved, 3 months later I was pregnant! I will always try herbal before synthetics from now on.

See all Provera reviews / ratings >>

Page last updated: 2013-02-10

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