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Last Updated: January 20, 2025

CLINICAL TRIALS PROFILE FOR NORPLANT


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All Clinical Trials for Norplant

Trial IDTitleStatusSponsorPhaseStart DateSummary
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.
NCT00710606 ↗ Comparison of Serum Contraceptive Hormone Levels Between Normal Weight and Obese Users of the NuvaRing® Completed Columbia University 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.
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.
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.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 6 of 6 entries

Clinical Trial Conditions for Norplant

Condition Name

11110-0.100.10.20.30.40.50.60.70.80.911.1MetrorrhagiaOvarian CancerOvarian CarcinomaPeriodontal Disease[disabled in preview]
Condition Name for Norplant
Intervention Trials
Metrorrhagia 1
Ovarian Cancer 1
Ovarian Carcinoma 1
Periodontal Disease 1
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Condition MeSH

3111000.511.522.53HemorrhageMetrorrhagiaOvarian NeoplasmsPeriodontal Diseases[disabled in preview]
Condition MeSH for Norplant
Intervention Trials
Hemorrhage 3
Metrorrhagia 1
Ovarian Neoplasms 1
Periodontal Diseases 1
[disabled in preview] 0
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Clinical Trial Locations for Norplant

Trials by Country

+
Trials by Country for Norplant
Location Trials
United States 27
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Trials by US State

+
Trials by US State for Norplant
Location Trials
New York 3
Missouri 2
Virginia 2
Pennsylvania 1
Oklahoma 1
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Clinical Trial Progress for Norplant

Clinical Trial Phase

28.6%14.3%57.1%000.511.522.533.54Phase 4Phase 2N/A[disabled in preview]
Clinical Trial Phase for Norplant
Clinical Trial Phase Trials
Phase 4 2
Phase 2 1
N/A 4
[disabled in preview] 0
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Clinical Trial Status

85.7%14.3%00123456CompletedUnknown status[disabled in preview]
Clinical Trial Status for Norplant
Clinical Trial Phase Trials
Completed 6
Unknown status 1
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Clinical Trial Sponsors for Norplant

Sponsor Name

trials0112233Columbia UniversityOrganonAmerican College of Obstetricians and Gynecologists[disabled in preview]
Sponsor Name for Norplant
Sponsor Trials
Columbia University 2
Organon 1
American College of Obstetricians and Gynecologists 1
[disabled in preview] 3
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Sponsor Type

72.7%18.2%9.1%0012345678OtherNIHIndustry[disabled in preview]
Sponsor Type for Norplant
Sponsor Trials
Other 8
NIH 2
Industry 1
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NORPLANT: Clinical Trials, Market Analysis, and Projections

Introduction

NORPLANT, a subdermal contraceptive implant, has been a significant player in the contraceptive market for several decades. This article will delve into the clinical trials, market analysis, and future projections for NORPLANT, providing a comprehensive overview of its efficacy, market trends, and future outlook.

Clinical Trials Overview

NORPLANT and NORPLANT-2 Implants

Clinical trials for NORPLANT and NORPLANT-2 implants have been extensive and global. A study involving 240 healthy women aged 18 to 40 years compared the efficacy of these two implant systems. Over three years, no pregnancies were recorded among women using NORPLANT implants, while two pregnancies occurred in the NORPLANT-2 group, resulting in a cumulative net pregnancy rate of 1.3 per 100 acceptors by the end of year three[1].

Pre-Introductory Clinical Trials

Pre-introductory clinical trials conducted in 17 countries across Latin America, Asia, and Africa between 1984 and 1991 involved 16,282 women. These trials showed gross cumulative pregnancy rates of less than 0.6 per 100 women in the first year, highlighting the high efficacy of NORPLANT implants[3].

Common Reasons for Discontinuation

The most common reasons for discontinuing the use of NORPLANT and NORPLANT-2 implants were bleeding disturbances and mood changes such as depression. Despite these issues, the continuation rates after one year were 59.4% for NORPLANT users and 77.2% for NORPLANT-2 users, with corresponding figures after three years being 46.1% and 51.7%, respectively[1].

Efficacy and Safety

Contraceptive Efficacy

NORPLANT implants have demonstrated high contraceptive efficacy, with pregnancy rates significantly lower than many other contraceptive methods. The implants release levonorgestrel, a progestin that prevents ovulation and thickens cervical mucus to prevent sperm penetration[1][3].

Side Effects and Health Implications

Common side effects include bleeding disturbances, weight gain, and slight decreases in blood pressure and hemoglobin levels. However, these side effects generally decrease over time, with fewer women discontinuing due to bleeding problems in subsequent years[1].

Market Analysis

Global Market Size and Growth

The global contraceptive devices market, which includes subdermal implants like NORPLANT, was valued at USD 11.16 billion in 2025 and is projected to grow at a compound annual growth rate (CAGR) of 6.0% from 2018 to 2025. Proactive government initiatives for population control and rising awareness in emerging countries are driving this growth[2].

Market Dominance

Major players in the market include Pfizer Inc., Bayer AG, and Allergan. These companies have dominated the market due to their extensive product portfolios and strong distribution networks[2].

Market Projections

North America Market

In North America, the subdermal contraceptive implants market is expected to decline significantly, with a compound annual growth rate (CAGR) of -66.7% from 2025 to 2030. This decline is attributed to various factors, including changes in consumer preferences and the availability of alternative contraceptive methods. The market revenue is projected to drop from USD 728.2 million in 2024 to USD 1.0 million by 2030[5].

Global Trends

Despite the decline in North America, the global market for contraceptive devices is expected to continue growing, driven by increasing demand in emerging markets. The rising awareness and proactive government initiatives in these regions are anticipated to create diverse opportunities for market players[2].

Male Contraception Trials

Norplant II for Male Contraception

Recent studies have explored the use of Norplant II implants in combination with testosterone for male contraception. These trials have shown that Norplant II implants plus testosterone enanthate (TE) injections can effectively suppress spermatogenesis to levels acceptable for contraceptive efficacy. However, the efficacy varies based on the route and dose of androgen administration[4].

Key Takeaways

  • High Efficacy: NORPLANT implants have demonstrated high contraceptive efficacy with minimal pregnancy rates.
  • Side Effects: Common side effects include bleeding disturbances and mood changes, which tend to decrease over time.
  • Market Trends: The global market for contraceptive devices is growing, but the North American market for subdermal implants is projected to decline.
  • Male Contraception: Norplant II implants show promise in male contraception when combined with appropriate androgen delivery systems.

FAQs

What is the primary active ingredient in NORPLANT implants?

The primary active ingredient in NORPLANT implants is levonorgestrel, a progestin.

How effective are NORPLANT implants in preventing pregnancy?

NORPLANT implants have been shown to have a cumulative net pregnancy rate of less than 1 per 100 women over three years, making them highly effective.

What are the common reasons for discontinuing NORPLANT implants?

The most common reasons for discontinuing NORPLANT implants are bleeding disturbances and mood changes such as depression.

Is NORPLANT being explored for male contraception?

Yes, Norplant II implants are being studied in combination with testosterone for male contraception, showing promising results in suppressing spermatogenesis.

What is the projected growth rate for the North American subdermal contraceptive implants market?

The North American subdermal contraceptive implants market is expected to decline at a CAGR of -66.7% from 2025 to 2030.

Sources

  1. Contraception with NORPLANT implants and NORPLANT-2 implants - PubMed
  2. Contraceptive Devices Market Size, Share | Report [2032] - Fortune Business Insights
  3. Pre-introductory clinical trials of Norplant implants - PubMed
  4. Levonorgestrel Implants (Norplant II) for Male Contraception Clinical - Oxford University Press
  5. North America Subdermal Contraceptive Implants Market Size - Grand View Research

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