Depo-Provera (Medroxyprogesterone Acetate) - Summary

DEPO-PROVERA SUMMARY

DEPO-PROVERA Contraceptive Injection contains medroxyprogesterone acetate, a derivative of progesterone, as its active ingredient. Medroxyprogesterone acetate is active by the parenteral and oral routes of administration.

DEPO-PROVERA Contraceptive Injection is indicated only for the prevention of pregnancy. To ensure that DEPO-PROVERA Contraceptive Injection is not administered inadvertently to a pregnant woman, the first injection must be given ONLY during the first 5 days of a normal menstrual period; ONLY within the first 5-days postpartum if not breast-feeding, and if exclusively breast-feeding, ONLY at the sixth postpartum week. The efficacy of DEPO-PROVERA Contraceptive Injection depends on adherence to the recommended dosage schedule (see DOSAGE AND ADMINISTRATION). It is a long-term injectable contraceptive in women when administered at 3-month (13-week) intervals. Dosage does not need to be adjusted for body weight.

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NEWS HIGHLIGHTS

Published Studies Related to Depo-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..

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Clinical Trials Related to Depo-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.

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.

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.

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 / COMMENTS

Depo-Provera review by 28 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		Birth Control
Dosage & duration:		150mg/ml taken every 10-13 weeks for the period of for 9 years
Other conditions:		none
Other drugs taken:		OTC pain relievers
		Reported Results
Benefits:		I was taking this drug as birth control, and it has been extremely effective. (No children, yet!) The fact that you only need to take it four times a year is great, so it is difficult to miss a dose. (Unlike the pill, which you take everyday, and missing it even once alters it's effectiveness.) As an added bonus, I no longer have my period, which were extremely painful and disrupted my life for a whole week every month. I no longer suffer from PMS symptoms, either. I can not complain about this drug at all.
Side effects:		I have not experienced any side effects from this medication. Losing my period was an anticipated side effect, and although many feel that this is too much for them and discontinue use of this drug, it is a good side effect for me. Also there are studies that show bone mineral density is affected by this drug, but I have undergone a bone density scan, with normal results. This is great, considering I have been on Depo for nine years now, since I turned nineteen and for most of my twenties.
Comments:		This drug is administered into a muscle by injection four times a year, by a physician. The shot is given every ten to thirteen weeks. Besides being used as birth control, it is also used to treat other conditions.

Depo-Provera review by 20 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		Contraception
Dosage & duration:		1 shot every 3 months (dosage frequency: 1 shot every 3 months) for the period of 3 months
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		I did not get pregnant while on the depo shot... but then again my sex life was shot due to the constant bleeding.
Side effects:		Side effects were horrific. I gained weight, developed horrible acne, and i was severely depressed the entire time. When choosing the depo shot i was excited to not have to worry about taking the pill, lightening or stopping my periods, and the guaruntee of contraception. Boy was i wrong. All of the previous side effects were bad enough, but after the first month on the shot, i continued to have my period for nearly 2 months straight. for some reason my period never stopped. The worst part about this contraceptive is that once you take the shot, there is no going back. I highly recommend a different birth control. I am now on the nuvaring and so far i am pleased with the results. Mild nausea at night the first week but that is my only complaint. Much better choice if you are looking to avoid pills. :)
Comments:		I recieved the shot at family planning about 3 years ago. Please do yourself a favor and look to other options before choosing this drug. My experience was the hardest 3 months of my life both emotionally and physically.

Depo-Provera review by 24 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		Birth Control
Dosage & duration:		One injection (dosage frequency: every 3 months) for the period of 6 months
Other conditions:		None
Other drugs taken:		None
		Reported Results
Benefits:		Birth Control
Side effects:		Massive weight gain, 22kgs (?48pounds) in the first 3months. Massive mood changes, bacame very depressed (weight gain didnt help that one) Was emotional about the smallest things. Anxiety attacks. Angry over small things. Nightmares and sleep walking and talking ? if these are side effect of that drug but there was a definate increase in both (esp sleep talking) when i was on the drug. Increased appitite (the weight didnt come from nowhere) was warned about pos weight gain but was told that if you controlled your eating youd be fine but my hunger was crazy i would eat a main meal and 1/2 hour later be starving like i hadnt eaten all day. I found it really hard to control my intake due to my excessive hunger. I also had heavy spotting the whole time i was on it and for about 5 months after i stopped the injections. I guess it was a very effective birth control as i had become depressed, overweight, had my period the whole time and was more interested in food than sex. Over all was not worth taking it, i actually regret taking it, was devestating for a 18year old at the time to go through. I also found it very hard to loose the weight during or afterwards, continued to gain weight for 6months after the last injection before any changes occured despite exercise and diet changes.
Comments:		Birth control, 2x doses over 6months before i decided to stop treatment.