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
Periodontal Disease	1
Pharmacokinetics	1
Bleeding	1
Contraception	1

Condition MeSH

Condition MeSH for NORPLANT
Intervention	Trials
Hemorrhage	3
Ovarian Neoplasms	1
Periodontal Diseases	1
Gingival Diseases	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
Utah	1
Texas	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
American College of Obstetricians and Gynecologists	1
Washington University School of Medicine	1

Sponsor Type

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

NORPLANT (levonorgestrel) — Clinical Trials Update, Market Analysis, and Projection

Last updated: May 6, 2026

What is NORPLANT and where is it positioned clinically?

NORPLANT is an implantable contraceptive delivering levonorgestrel via subdermal capsules. It is marketed as a long-acting reversible contraception (LARC) option targeting pregnancy prevention.

Clinical status (global, practical framing):

• NORPLANT is an established product with a mature market footprint, where newer LARC competitors (notably etonogestrel implants) have expanded share in many geographies.
• In the clinical development sense (new pivotal programs), NORPLANT’s role is largely historical and maintenance rather than a new R&D engine, because the molecule and delivery form have long been established.

Evidence base (regulatory/clinical record characteristics):

• NORPLANT’s clinical value is tied to implant pharmacokinetics, pregnancy prevention efficacy, and safety outcomes typical of levonorgestrel-releasing systems.
• Most contemporary trial activity in this therapeutic category clusters around next-generation implants and comparative effectiveness against competing devices rather than new NORPLANT-specific phase programs.

What does the clinical trials update show right now?

A current “active trials” posture for NORPLANT is typically characterized by:

• Post-authorization observational studies (effectiveness, continuation rates, bleeding patterns, device management).
• Comparative or real-world contraception studies versus other implant brands and formulations.
• Regulatory life-cycle work (label maintenance, local approvals, pharmacovigilance reporting), rather than large-scale late-phase trials.

What investors typically look for with NORPLANT:

• Whether any new randomized head-to-head program is underway using NORPLANT as the lead implant.
• Whether any new indication is being pursued (most markets restrict NORPLANT to contraception).
• Whether the product is moving into replacement tenders where device procurement favors competing implant systems.

Given NORPLANT’s mature status, the decisive “clinical update” for near-term commercial outcomes is usually not trial results; it is whether the brand remains in national procurement and private formularies.

How does NORPLANT perform versus competing LARC implants in market reality?

NORPLANT competes in a concentrated LARC segment where switching costs are driven by procurement contracts, clinician familiarity, and availability of insertion/removal training.

Key competitive pressure points:

• Implant share shift to etonogestrel systems in many markets (often with longer effective duration and strong continuation profiles).
• Formulary and tender dynamics: procurement decisions can displace older implant brands even when clinical profiles remain acceptable.
• Program-level barriers: insertion/removal training, supply chain reliability, and service ecosystem matter more than incremental pharmacology for many health systems.

Commercial implication:

• NORPLANT demand is most elastic where public-sector procurement is competitive and where newer implants secure framework agreements.

Where is NORPLANT sold and how does that affect demand?

For mature contraceptive implant products, demand tracks closely to:

• Public health program procurement cycles
• Provider network uptake
• Forecasted contraceptive demand (including adolescent and family planning coverage targets)
• Regulatory tender outcomes

In markets where NORPLANT retains reimbursement and contract status, volumes persist. In markets where newer implants take lead positions, NORPLANT volumes compress or move into niche/private channels.

What is the market structure for contraceptive implants relevant to NORPLANT projections?

Contraceptive implants are a mature, high-penetration LARC category dominated by a small number of branded systems. Industry economics typically follow:

• Tender-led pricing in public sector
• Distribution margins and service logistics for provider-administered products
• Low churn at the individual patient level once inserted, since method switching occurs at removal or continuation points

Projection drivers for NORPLANT specifically:

• Whether NORPLANT remains in national or regional procurement lists
• Whether substitution to competitor implants continues
• Price erosion from tender competition
• Supply availability and product continuity across contract periods

Market analysis: demand, pricing, and competitive substitution

NORPLANT market performance is generally governed by three observable forces:

1) Competitive displacement

• LARC is a “device category.” Even with comparable efficacy, brands can lose share if procurement favors competing systems.
• The category’s dominant competitors often build clinician familiarity, program relationships, and predictable supply.

NORPLANT risk profile: steady market presence is vulnerable to tender-based substitution.

2) Tender cycles

• Public-sector buyers award contracts on multi-year cycles.
• When contracts rotate, older products can be replaced even if clinical performance remains acceptable.

NORPLANT forecasting implication: near-term revenue is sensitive to whether NORPLANT retains procurement status.

3) Patient continuation and method churn

• Once inserted, continuation is affected by bleeding pattern tolerance, removal access, and counseling quality.
• Real-world effectiveness is typically high across implant brands, but brand-specific bleeding profiles and insertion practices can affect continuation and re-insertion behavior.

Commercial implication: counseling and provider training influence repeat insertion volumes for the same method family.

Projection framework for NORPLANT (base, downside, upside)

Because NORPLANT is a mature, procurement-sensitive product, the projection must be framed around share and contract continuity rather than new clinical adoption.

Projection drivers used for commercial modeling:

• Market growth in contraceptive demand and LARC uptake
• Share maintenance vs. displacement by competing implants
• Price trend under tender pressure
• Supply continuity (stockouts reduce realized demand)

Scenario logic (directional):

• Base case: modest category growth offsets mild NORPLANT share erosion; contract retention stabilizes volumes.
• Downside: loss of one or more procurement frameworks accelerates substitution; price declines or volume declines compound.
• Upside: contract retention + targeted private uptake holds share; tender pricing stabilizes for NORPLANT.

Clinical and regulatory milestones to watch (commercially relevant)

Even without large new pivotal NORPLANT trials, the “update” that moves the needle comes from:

• Procurement re-listing decisions
• Label changes tied to local approvals
• Safety signal trends in pharmacovigilance databases
• Availability of insertion kits and supply chain continuity

Key takeaways for business planning

• NORPLANT’s near-term commercial outlook is determined more by tender and procurement continuity than by new clinical phase results.
• Competitive substitution risk is structural in LARC, with buyers frequently favoring newer implant systems.
• Forecasting should prioritize share retention, contract cycles, and pricing under tenders rather than expecting new NORPLANT-specific late-phase efficacy breakthroughs.

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Key Takeaways

1. NORPLANT is a mature levonorgestrel implant product; clinical “updates” in practice center on post-authorization evidence and real-world performance rather than new pivotal trials.
2. The dominant commercial lever is procurement: market outcomes hinge on whether NORPLANT stays listed in national or regional tender frameworks.
3. Projection modeling should weight share substitution by competing implants and tender-led price erosion more than baseline category growth.

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FAQs

1. Is NORPLANT still being used as a leading contraceptive implant in major markets?
   It remains used where it retains procurement and reimbursement status; displacement risk depends on tender outcomes versus competing etonogestrel implants.

2. Do recent NORPLANT-specific phase trials drive near-term commercialization?
   Near-term sales are more sensitive to procurement and supply continuity than to new late-phase trial generation for a mature product.

3. What is the biggest commercial risk for NORPLANT?
   Loss of procurement frameworks to competitor implant systems and resulting volume substitution.

4. What is the biggest commercial upside for NORPLANT?
   Contract retention plus stable tender pricing that prevents share erosion, supported by consistent availability and provider training.

5. How should forecasts for NORPLANT be constructed?
   Use scenario-based share and tender-cycle assumptions anchored to procurement retention, price trends, and realized supply.

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References (APA)

[1] World Health Organization. (n.d.). Contraceptive implant guidance and related program information. World Health Organization.
[2] U.S. Food and Drug Administration. (n.d.). Product label and safety information for levonorgestrel implant contraceptives (NORPLANT and related entries). FDA.
[3] EMA. (n.d.). Levonorgestrel contraceptive implant product information and assessment materials where available. European Medicines Agency.