CLINICAL TRIALS PROFILE FOR DEPO-SUBQ PROVERA 104

All Clinical Trials for Depo-subq Provera 104

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000897 ↗	A Study to Evaluate the Effects of Different Methods of Birth Control on the Drug Actions of Zidovudine (an Anti-HIV Drug) in HIV-Positive Women and to Compare Zidovudine Metabolism in Men and Women	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	The purpose of this study is to look at the effects of different methods of birth control (oral and injectable) on how the body absorbs, makes available, and removes zidovudine (ZDV). This study will also evaluate the differences in men and women in how the body absorbs, makes available, and removes ZDV. Past research has shown that the effectiveness of ZDV as an anti-HIV drug might be decreased in individuals who use certain methods of birth control. ZDV may also have different effects in men compared to women.
NCT00003179 ↗	Surgery Plus Medroxyprogesterone in Preventing Endometrial Cancer	Terminated	National Cancer Institute (NCI)	Phase 2	1998-11-01	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.
NCT00003179 ↗	Surgery Plus Medroxyprogesterone in Preventing Endometrial Cancer	Terminated	Gynecologic Oncology Group	Phase 2	1998-11-01	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.
NCT00016601 ↗	Depo-Medroxyprogesterone Acetate (DMPA, Depo-Provera) Use With Certain Anti-HIV Drugs in HIV-Infected Women	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	N/A	2001-06-01	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.
NCT00016601 ↗	Depo-Medroxyprogesterone Acetate (DMPA, Depo-Provera) Use With Certain Anti-HIV Drugs in HIV-Infected Women	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	2001-06-01	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.

Clinical Trial Conditions for Depo-subq Provera 104

Condition Name

Condition Name for Depo-subq Provera 104
Intervention	Trials
Contraception	12
Dysfunctional Uterine Bleeding	3
HIV	3
HIV Infections	3

Condition MeSH

Condition MeSH for Depo-subq Provera 104
Intervention	Trials
Hemorrhage	5
Uterine Hemorrhage	4
Metrorrhagia	4
Endometrial Neoplasms	3

Clinical Trial Locations for Depo-subq Provera 104

Trials by Country

Trials by Country for Depo-subq Provera 104
Location	Trials
United States	161
Dominican Republic	3
Zimbabwe	2
Norway	2
Uganda	2

Trials by US State

Trials by US State for Depo-subq Provera 104
Location	Trials
California	13
Pennsylvania	11
Texas	8
Ohio	7
North Carolina	7

Clinical Trial Progress for Depo-subq Provera 104

Clinical Trial Phase

Clinical Trial Phase for Depo-subq Provera 104
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	6
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Depo-subq Provera 104
Clinical Trial Phase	Trials
Completed	37
Terminated	8
Recruiting	6

Clinical Trial Sponsors for Depo-subq Provera 104

Sponsor Name

Sponsor Name for Depo-subq Provera 104
Sponsor	Trials
FHI 360	5
National Institute of Allergy and Infectious Diseases (NIAID)	4
National Cancer Institute (NCI)	4

Sponsor Type

Sponsor Type for Depo-subq Provera 104
Sponsor	Trials
Other	71
Industry	12
NIH	12

DEPO-SUBQ PROVERA 104: Clinical Trials, Market Analysis, and Projections

Introduction

DEPO-SUBQ PROVERA 104, a subcutaneous injectable contraceptive and treatment for endometriosis-associated pain, has undergone extensive clinical trials to establish its efficacy and safety. This article delves into the key findings from these trials, market analysis, and future projections for this medication.

Clinical Trials Overview

Contraceptive Efficacy

In three open-label clinical studies, DEPO-SUBQ PROVERA 104 was administered to 2042 healthy, sexually active, nonpregnant women aged 18 to 49 years. No pregnancies were detected among these women over a period of up to one year, indicating a Pearl Index pregnancy rate of 0 pregnancies per 100 women-years of use for women under 36 years old[1][3].

Endometriosis-Associated Pain

Two active comparator-controlled studies (Studies 268 and 270) evaluated the efficacy of DEPO-SUBQ PROVERA 104 in reducing endometriosis-associated pain. These studies involved pre-menopausal women with laparoscopically diagnosed endometriosis and persistent pain symptoms. The treatment consisted of 104 mg of DEPO-SUBQ PROVERA 104 administered subcutaneously every three months for six months. The results showed significant reduction in pain symptoms compared to the comparator, leuprolide[1][3].

Pharmacokinetics and Pharmacodynamics

Absorption and Serum Concentrations

Following a single subcutaneous injection, serum medroxyprogesterone acetate (MPA) concentrations reach ≥0.2 ng/mL within 24 hours, with the mean Tmax attained approximately one week after injection. The pharmacokinetics of DEPO-SUBQ PROVERA 104 were found to be similar across different racial groups and were not significantly affected by body weight[3].

Bone Mineral Density (BMD)

Clinical trials revealed that DEPO-SUBQ PROVERA 104 is associated with significant loss of BMD, particularly in the lumbar spine, total hip, and femoral neck. This loss is a concern, especially during adolescence and early adulthood, as it may impact peak bone mass and increase the risk of osteoporotic fractures later in life. Studies showed partial recovery of BMD after discontinuation, but full recovery was not observed in all cases[1][4].

Adverse Reactions and Safety Profile

Common Adverse Reactions

Common adverse reactions include changes in menstrual bleeding patterns, such as amenorrhea, irregular spotting or bleeding, and weight gain. The mean weight gain was approximately 3.5 lb (1.6 kg) in the first year and 7.5 lb (3.4 kg) over two years. Injection site reactions, such as pain, tenderness, and nodule formation, were also reported[4][5].

Menstrual Changes

Most women experienced changes in menstrual bleeding, with amenorrhea becoming more common with longer-term use. This is consistent with the expected endometrial thinning effects of the medication[4].

Market Analysis

Current Market Position

DEPO-SUBQ PROVERA 104 is positioned as a convenient and effective contraceptive option, particularly for women who prefer a long-acting method with minimal user intervention. Its additional indication for managing endometriosis-associated pain expands its market potential.

Competitive Landscape

The contraceptive market is highly competitive, with various hormonal and non-hormonal options available. However, DEPO-SUBQ PROVERA 104's unique subcutaneous administration and dual indications set it apart from other injectable contraceptives like DMPA-IM.

Global Access and Initiatives

PATH, a global health organization, is working to introduce DEPO-SUBQ PROVERA 104 in the Uniject injection system to enhance access in developing countries. This initiative aims to generate data, facilitate decision-making, and coordinate global support for the product's rollout[2].

Market Projections

Growth Potential

Given its high efficacy and convenience, DEPO-SUBQ PROVERA 104 is expected to see significant growth in the contraceptive market. The expanding awareness and acceptance of long-acting reversible contraceptives (LARCs) will likely drive demand.

Emerging Markets

The introduction of DEPO-SUBQ PROVERA 104 in developing countries through initiatives like PATH's Uniject system is anticipated to increase its global market share. This expansion will be driven by the need for reliable and accessible contraceptive options in these regions.

Challenges and Opportunities

Despite its benefits, the medication faces challenges related to BMD loss and potential long-term effects on bone health. Addressing these concerns through ongoing research and patient education will be crucial for maintaining market confidence.

"Use of depo-subQ provera 104 reduces serum estrogen levels and is associated with significant loss of bone mineral density (BMD). This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion."[4]

Regulatory Considerations

FDA Approval and Guidelines

DEPO-SUBQ PROVERA 104 has been approved by the FDA for the prevention of pregnancy and the management of endometriosis-associated pain. Regulatory guidelines emphasize the importance of monitoring BMD and informing patients about potential risks[3].

Patient Education and Training

Self-Administration

Efforts to enable self-administration of DEPO-SUBQ PROVERA 104, such as through the Uniject system, are underway. This requires comprehensive patient training and support to ensure safe and effective use outside clinical settings[2].

Conclusion

DEPO-SUBQ PROVERA 104 has demonstrated strong efficacy in clinical trials as both a contraceptive and a treatment for endometriosis-associated pain. While it offers significant benefits, it also comes with important safety considerations, particularly regarding BMD loss. As the market continues to evolve, addressing these concerns and expanding access, especially in developing countries, will be key to its long-term success.

Key Takeaways

• High Contraceptive Efficacy: No pregnancies detected in clinical trials involving over 2000 women.
• Effective for Endometriosis: Significant reduction in endometriosis-associated pain in clinical studies.
• BMD Concerns: Associated with significant loss of bone mineral density, particularly in younger women.
• Common Adverse Reactions: Changes in menstrual bleeding, weight gain, and injection site reactions.
• Market Growth Potential: Expected growth driven by increasing demand for LARCs and expanding global access.
• Regulatory and Patient Education: Ongoing monitoring and education are crucial for safe use.

FAQs

Q: What is DEPO-SUBQ PROVERA 104 used for?

A: DEPO-SUBQ PROVERA 104 is used for the prevention of pregnancy and the management of endometriosis-associated pain.

Q: How effective is DEPO-SUBQ PROVERA 104 as a contraceptive?

A: DEPO-SUBQ PROVERA 104 has shown 100% efficacy in preventing pregnancy in clinical trials involving over 2000 women over a period of up to one year.

Q: What are the common adverse reactions associated with DEPO-SUBQ PROVERA 104?

A: Common adverse reactions include changes in menstrual bleeding patterns, weight gain, and injection site reactions such as pain and tenderness.

Q: Does DEPO-SUBQ PROVERA 104 affect bone mineral density?

A: Yes, DEPO-SUBQ PROVERA 104 is associated with significant loss of bone mineral density, particularly in the lumbar spine, total hip, and femoral neck.

Q: Can DEPO-SUBQ PROVERA 104 be self-administered?

A: Efforts are underway to enable self-administration through systems like Uniject, but this requires comprehensive patient training and support.

Sources

1. Pfizer Medical Information: DEPO-SUBQ PROVERA 104 Clinical Studies.
2. PATH: Home-Based Administration of depo-subQ provera 104 in the Uniject Injection System.
3. FDA: DEPO-SUBQ PROVERA 104 Label.
4. Pfizer Medical Information: DEPO-SUBQ PROVERA 104 Warnings and Precautions.
5. Pfizer Medical Information: DEPO-SUBQ PROVERA 104 (medroxyprogesterone acetate) - US.

Last updated: 2025-01-04