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.
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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 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.
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.
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NEWS HIGHLIGHTS
Published Studies Related to Provera (Medroxyprogesterone)
Metabolic and endocrine effects of metformin and metformin plus cyclic medroxyprogesterone acetate in women with polycystic ovary syndrome. [2009.04]
OBJECTIVE: To evaluate the metabolic and endocrine effects of treatment with cyclic medroxyprogesterone acetate (MPA) plus metformin compared with metformin alone in women with PCOS... CONCLUSION: There were no adverse effects of short-term cyclic MPA plus metformin treatment on metabolic parameters or insulin resistance in patients with PCOS over a 3-month treatment period.
Implanon versus medroxyprogesterone acetate: effects on pain scores in patients with symptomatic endometriosis--a pilot study. [2009.01]
BACKGROUND: Implanon has been reported to be effective in the treatment of dysmenorrhea. We compared the therapeutic efficacies of depot medroxyprogesterone acetate (DMPA) and Implanon with regard to pain relief in women with endometriosis... CONCLUSION: Concerning pain relief, the therapeutic efficacy of the contraceptive implant Implanon is not inferior to that of DMPA in symptomatic endometriosis.
Effects of either tibolone or continuous combined transdermal estradiol with medroxyprogesterone acetate on coagulatory factors and lipoprotein(a) in menopause. [2009]
BACKGROUND/AIM: The aim of this prospective controlled study was to compare the effects of two therapies for menopause on factor VII (FVII) and hemostatic variables... CONCLUSION: Our results show that tibolone induces a significant reduction in FVIIc and Lp(a) and a greater enhancement of factors promoting fibrinolysis than the TTS E2/MPA regimen.
Clinical and metabolic effects of medroxyprogesterone acetate and ethinyl estradiol plus drospirenone in women with polycystic ovary syndrome. [2008.10]
OBJECTIVES: To investigate the effects of treatment with medroxyprogesterone acetate (MPA), 10 days per month for 6 months, on lipid and carbohydrate metabolism in women with polycystic ovary syndrome (PCOS)... CONCLUSION: Treatment of PCOS patients with MPA provided good menstrual cycle control, beneficial changes in hormonal values associated with hyperandrogenism, and no significant changes in lipid or carbohydrate metabolism.
Effect of mifepristone on the expression of endometrial secretory leukocyte protease inhibitor in new medroxyprogesterone acetate users. [2008.09]
The effect of mifepristone on the expression of secretory leukocyte protease inhibitor (SLPI) in the endometrium of women using depot medroxyprogesterone acetate (DMPA) was investigated in this randomized, placebo-controlled trial. The study showed that the administration of DMPA led to a substantial inhibition of endometrial SLPI protein and mRNA, and that the addition of mifepristone to DMPA-exposed endometrium partially restored the expression of glandular SLPI..
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.
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.
Pilot Study of Femring Estrogen Supplementation During Depo-Provera Initiation [Recruiting]
Many women choose Depo-Provera for birth control because it is easy to use and very
effective. However, a significant number of Depo-Provera users experience irregular bleeding
during the first 90 days. Many users discontinue after their first injection due to irregular
bleeding. This study will evaluate the effect of using an estrogen vaginal ring during the
first 90 days of Depo-Provera use to see if it is acceptable to women and whether it
decreases irregular bleeding during the first 90 days of use and increases continuation to a
second injection.
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.
Medroxyprogesterone or Interferon and/or Aldesleukin in Treating Patients With Metastatic Kidney Cancer [Active, not recruiting]
RATIONALE: Medroxyprogesterone may help shrink or slow the growth of kidney cancer.
Interferon may interfere with the growth of tumor cells. Aldesleukin may stimulate white
blood cells to kill tumor cells. It is not yet known whether giving medroxyprogesterone,
interferon, or aldesleukin alone is more effective than giving interferon together with
aldesleukin in treating kidney cancer.
PURPOSE: This randomized phase III trial is studying medroxyprogesterone, interferon, or
aldesleukin to see how well they work when given alone compared to interferon combined with
aldesleukin in treating patients with metastatic kidney cancer.
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PATIENT REVIEWS / RATINGS / COMMENTSBased 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. |
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| | 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. |
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| | 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. |
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Page last updated: 2009-10-20
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