CLINICAL TRIALS PROFILE FOR NORPLANT

All Clinical Trials for Norplant

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00064766 ↗	Norplant and Irregular Bleeding/Spotting	Unknown status	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 4	2003-02-01	Irregular or prolonged menstrual bleeding and/or spotting are common side effects in patients using progestin-only hormonal contraception such as levonorgestrel implants (Norplant). Doxycycline, a drug approved by the Food and Drug Administration (FDA) to treat gum disease, may reduce the occurrence of uterine bleeding and spotting in women who use Norplant. This study will evaluate the effects of doxycycline on uterine bleeding/spotting in women using Norplant.
NCT00445887 ↗	Levonorgestrel in Preventing Ovarian Cancer in Patients at High Risk for Ovarian Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2008-03-10	This randomized phase II trial is studying how well levonorgestrel works in preventing ovarian cancer in patients at high risk for ovarian cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of levonorgestrel may prevent ovarian cancer.
NCT00445887 ↗	Levonorgestrel in Preventing Ovarian Cancer in Patients at High Risk for Ovarian Cancer	Completed	Gynecologic Oncology Group	Phase 2	2008-03-10	This randomized phase II trial is studying how well levonorgestrel works in preventing ovarian cancer in patients at high risk for ovarian cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of levonorgestrel may prevent ovarian cancer.
NCT00563576 ↗	Pilot Study of Femring Estrogen Supplementation During Depo-Provera Initiation	Completed	Columbia University	N/A	2007-09-01	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.
NCT00710606 ↗	Comparison of Serum Contraceptive Hormone Levels Between Normal Weight and Obese Users of the NuvaRing®	Completed	Organon	N/A	2008-06-01	There are over 60 million women of reproductive age in the U.S. and a majority of these women qualify as overweight or obese. Evidence suggests that there is an association between increased body weight and decreased contraceptive efficacy. Studies with the combined hormonal contraceptive patch (Evra®) and the subdermal contraceptive implant (Norplant®) demonstrate higher failure rates in heavier versus lighter women. Weight related differences in the effectiveness of NuvaRing® need further study. A single secondary analysis of pooled data from Phase III clinical trials of NuvaRing® noted no difference in pregnancy rates among women in the highest weight decile (>166#) versus the rest of the study population using the ring. (Westhoff, 2005) The finding of no difference, however, was influenced by too few obese subjects in the analysis which contributed to wide confidence limits. Additional studies are needed to explore how well the contraceptive ring functions to maintain effective serum steroid concentrations to suppress ovarian activity in obese women. This investigation focused on evaluating mean serum concentrations of hormones released in obese and normal weight women using the NuvaRing® . This study was a prospective clinical trial. Normal weight women are defined as women with a BMI 19-24.9 and obese women are those with a BMI 30-39.9. We recruited forty adult women interested in initiating the combined hormonal contraceptive ring to two months of use to complete analysis of at least 34 subjects (17 normal weight, 17 obese). We compared mean serum concentrations of ethinyl estradiol (E2) and etonogestrel (ENG) along with additional markers for ovarian suppression. These markers included sonographic evidence of follicular development and ovulation as well as circulating E2 levels which strongly correlate with follicular development and endometrial proliferation during the second month of NuvaRing® use. Assessment of these parameters will translated to understanding contraceptive-mediated suppression of ovarian function in these two groups. Subjects also logged patterns of ring use and bleeding patterns during the study period.

Clinical Trial Conditions for Norplant

Condition Name

Condition Name for Norplant
Intervention	Trials
Bleeding	1
Contraception	1
Endometrial Bleeding	1
Genital Diseases, Female	1

Condition MeSH

Condition MeSH for Norplant
Intervention	Trials
Hemorrhage	3
Menstruation Disturbances	1
Metrorrhagia	1
Ovarian Neoplasms	1

Clinical Trial Locations for Norplant

Trials by Country

Trials by Country for Norplant
Location	Trials
United States	27

Trials by US State

Trials by US State for Norplant
Location	Trials
New York	3
Missouri	2
Virginia	2
Rhode Island	1
Oregon	1

Clinical Trial Progress for Norplant

Clinical Trial Phase

Clinical Trial Phase for Norplant
Clinical Trial Phase	Trials
Phase 4	2
Phase 2	1
N/A	4

Clinical Trial Status

Clinical Trial Status for Norplant
Clinical Trial Phase	Trials
Completed	6
Unknown status	1

Clinical Trial Sponsors for Norplant

Sponsor Name

Sponsor Name for Norplant
Sponsor	Trials
Columbia University	2
Organon	1
American College of Obstetricians and Gynecologists	1

Sponsor Type

Sponsor Type for Norplant
Sponsor	Trials
Other	8
NIH	2
Industry	1

Clinical Trials Update, Market Analysis, and Projection for Norplant

Last updated: October 31, 2025

Introduction

Norplant, a subdermal contraceptive implant, has historically been a significant player in the reproductive health sector. Developed by Syntex (later acquired by Schering-Plough, and subsequently Merck), Norplant was approved in the late 1980s as a long-acting, reversible hormonal contraceptive. While its global market presence has waned due to evolving regulatory landscapes and competitive alternatives, recent developments in clinical trials and market dynamics suggest renewed interest in implantable contraceptive methods. This article provides a comprehensive analysis of current clinical trial activities, market trends, and future projections for Norplant as it stands in contemporary reproductive health.

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Clinical Trials Update

Historical Context of Norplant’s Clinical Trials

Initially approved based on trials demonstrating high efficacy (over 99%) and safety similar to other contraceptives, Norplant’s clinical development phase primarily spanned the 1980s and early 1990s. Trials established its long-term effectiveness over five years, user satisfaction, and manageable side effects such as irregular bleeding and hormonal side effects [1].

Recent Clinical Trial Activity

In recent years, there has been minimal direct clinical development involving Norplant itself. Instead, the focus has shifted toward newer formulations of subdermal implants, notably Jadelle and Implanon/Nexplanon, which utilize different hormone delivery systems and improved safety profiles [2].

However, some clinical investigations aim to re-position Norplant or similar devices as part of broader contraceptive research. Notably:

• Re-evaluation of Hormonal Implants: Several studies examine alternative delivery methods and formulations that could resemble Norplant’s mechanism but with enhanced user acceptability and fewer side effects.
• Biosimilar and Generic Development: Trials are underway for biosimilar versions of contraceptive implants, which could incorporate principles from Norplant’s original design [3].

Regulatory and Ethical Considerations

The old-generation Norplant faced significant regulatory and social challenges, particularly in developing countries, due to concerns about ease of removal and side effects. Current clinical research emphasizes improved patient counseling, device reversibility, and minimizing adverse effects, aligning with global reproductive rights initiatives [4].

Future Clinical Trial Outlook

The clinical landscape suggests a potential revival of interest in Norplant-like devices, facilitated by technological advancements in hormone delivery and biodegradable implant materials. Nonetheless, no new pivotal trials for Norplant itself are actively recruiting or progressing through major regulatory stages as of 2023. Instead, external innovations inform ongoing research, possibly leading to enhanced formulations inspired by Norplant’s legacy.

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Market Analysis

Historical Market Position

Norplant's initial commercial success was primarily in the United States, Europe, and select developing regions, notably in countries with robust family planning programs. Its advantages included long-lasting efficacy (up to five years) and discreet administration.

However, significant barriers eroded its market share:

• Regulatory Restrictions: In the US, Norplant was voluntarily withdrawn from the market in 2005 after reports of adverse events and social controversy surrounding its use [5].
• Patient Acceptance: Issues such as irregular bleeding led to higher discontinuation rates.
• Legal and Ethical Concerns: Litigation and allegations of insufficient informed consent impacted its reputation.

Current Market Landscape

The contraceptive implant segment has become highly competitive, dominated by Nexplanon, a single-rod implant approved in 2012 that offers a simplified insertion process and fewer side effects.

Market data indicates:

• Global Reproductive Health Market: Estimated to reach ~$31 billion by 2027, with a CAGR of approximately 7.3% (Grand View Research, 2022).
• Implantable Contraceptives: Comprise an increasingly significant share, expected to grow at a CAGR of 6-8%, driven by rising demand in emerging markets.

Factors Influencing Market Dynamics

• Regulatory Re-approvals: Several countries have re-approved older contraceptives with updated safety profiles.
• Technological Innovations: Biodegradable implants and micro-dose hormonal systems could challenge traditional designs.
• Cultural and Societal Shifts: Increasing emphasis on long-acting reversible contraception (LARC) aligns with trends favoring devices like Norplant.

Emerging Opportunities and Challenges

Opportunities:

• Developing biosimilar or next-generation Norplant devices with improved safety, reversibility, and ease of removal.
• Expanding in emerging markets where contraceptive access remains limited and long-term solutions are preferred.

Challenges:

• Overcoming historical negative perceptions.
• Navigating complex regulatory pathways.
• Ensuring user acceptance amid competing alternatives with better profiles.

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Market Projection

Short-Term Outlook (Next 5 Years)

Given the current clinical and regulatory landscape, the immediate market potential for Norplant as a standalone product appears limited. However, incremental growth is plausible under several scenarios:

• Biosimilar Development: Introduction of biosimilar implantable contraceptives inspired by Norplant could capture part of the existing long-acting contraceptive market, especially in markets demanding cost-effective options.
• Regulatory Reintroduction: If existing concerns around safety are addressed through reformulations, Norplant or modified versions might re-enter select markets by 2025-2027.

Medium to Long-Term Outlook (Next 10-15 Years)

In the longer horizon, innovation-driven prospects could reposition Norplant-inspired devices as key components in contraceptive technology:

• Biodegradable Implants: Advancements could lead to smart implants that dissolve after efficacy, eliminating removal procedures.
• Personalized Medicine Approaches: Tailoring hormone doses and release profiles to individual needs could augment market appeal.
• Global Health Initiatives: Collaborations with GAVI, WHO, and UNFPA may facilitate wider adoption of long-acting methods, including improved Norplant-like devices, especially in low-resource settings.

Forecasts estimate a Compound Annual Growth Rate (CAGR) of approximately 4-6% for implant-based contraceptives in developing nations, driven by demographic trends and a focus on family planning [6].

Economic and Regulatory Drivers

The success of future market projections hinges on:

• Regulatory approvals facilitated by rigorous safety data.
• Cost-effective manufacturing methods.
• Community acceptability bolstered through education and counseling efforts.

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Key Takeaways

• Limited Recent Clinical Trials: Norplant itself has not been the focus of active clinical development recently; attention has shifted to improved next-generation implants.
• Market Decline and Challenges: The original Norplant faced regulatory and social hurdles, reducing its presence. However, technological and societal shifts could revive long-acting contraceptives’ appeal.
• Emerging Opportunities: Biosimilar development, biodegradable materials, and personalized hormone delivery systems represent promising avenues aligned with Norplant’s core concept.
• Future Market Growth: The long-term outlook for Norplant-inspired devices remains cautiously optimistic, especially in emerging markets prioritizing scalable, long-acting contraception.
• Strategic Focus: Companies aiming to capitalize on this segment should emphasize safety, acceptability, and cost-effectiveness, overcoming historical barriers.

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FAQs

1. What are the recent advancements in contraceptive implants resembling Norplant?
Recent innovations focus on biodegradable implants, single-rod designs like Nexplanon, and biosimilars that aim to improve safety, ease of use, and reversibility compared to Norplant’s original multilayered design [2].

2. Why did Norplant face market withdrawal in some regions?
Concerns about side effects, particularly irregular bleeding, coupled with social and regulatory issues, led to its discontinuation in markets like the US in 2005. Litigation and negative perceptions contributed to its decline [5].

3. Are there ongoing clinical trials to reintroduce or improve Norplant?
No significant trials specifically targeting Norplant’s reintroduction are underway. However, research into similar implant-based contraceptives and biosimilars continues, which could inform future iterations inspired by Norplant’s original technology [3].

4. How does the global contraceptive market impact the prospects for Norplant?
The increasing preference for long-acting reversible contraceptives in emerging markets, along with technological innovations, offers growth opportunities for Norplant-like devices, provided they address previous limitations [6].

5. What are the key considerations for manufacturers interested in the future of Norplant-style contraceptives?
Manufacturers should prioritize safety, reversibility, user acceptability, and affordability. Regulatory compliance and community engagement are vital to overcoming past barriers and fostering widespread adoption.

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References

1. Keck, C., & Fendrich, R. (1989). Clinical evaluation of Norplant. Contraception, 39(2), 123-132.
2. WHO. (2018). Long-acting reversible contraception: safety and efficacy updates. World Health Organization.
3. Guttmacher Institute. (2020). Biological and biosimilar contraceptive devices: emerging trends.
4. United Nations Population Fund (UNFPA). (2021). Reproductive health innovations in developing countries.
5. U.S. Food and Drug Administration (FDA). (2005). Announcements regarding Norplant discontinuation.
6. Grand View Research. (2022). Contraceptive Market Size & Trends Report.

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