CLINICAL TRIALS PROFILE FOR LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

All Clinical Trials for LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05233956 ↗	Levonorgestrel Intrauterine System Effects on Hemoglobin and Serum Ferritin Among Anemic Women in Kenya	Recruiting	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	N/A	2023-10-23	Women with mild/moderate anemia who are seeking contraception will be randomized to a levonorgestrel (LNG) intrauterine system (IUS) or an LNG/ethinyl estradiol (EE)/ferrous fumarate combined oral contraceptive (COC) regimen and followed prospectively for 18 months. Approximately 600 participants will be enrolled. The primary hypothesis is that the mean change in hemoglobin concentration will be significantly higher in the group assigned to the LNG IUS compared to the group assigned to COCs
NCT05233956 ↗	Levonorgestrel Intrauterine System Effects on Hemoglobin and Serum Ferritin Among Anemic Women in Kenya	Recruiting	FHI 360	N/A	2023-10-23	Women with mild/moderate anemia who are seeking contraception will be randomized to a levonorgestrel (LNG) intrauterine system (IUS) or an LNG/ethinyl estradiol (EE)/ferrous fumarate combined oral contraceptive (COC) regimen and followed prospectively for 18 months. Approximately 600 participants will be enrolled. The primary hypothesis is that the mean change in hemoglobin concentration will be significantly higher in the group assigned to the LNG IUS compared to the group assigned to COCs

Clinical Trial Conditions for LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Condition Name

Condition Name for LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
Intervention	Trials
Anemia	1

Condition MeSH

Condition MeSH for LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
Intervention	Trials
Anemia	1

Clinical Trial Locations for LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Trials by Country

Trials by Country for LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
Location	Trials
Kenya	1

Clinical Trial Progress for LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Clinical Trial Phase

Clinical Trial Phase for LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
Clinical Trial Phase	Trials
N/A	1

Clinical Trial Status

Clinical Trial Status for LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
Clinical Trial Phase	Trials
Recruiting	1

Clinical Trial Sponsors for LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Sponsor Name

Sponsor Name for LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
Sponsor	Trials
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	1
FHI 360	1

Sponsor Type

Sponsor Type for LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
Sponsor	Trials
NIH	1
Other	1

Summary
Levonorgestrel, ethinyl estradiol, and ferrous fumarate are components in combined oral contraceptives with supplemental iron. Currently, no major clinical trials are explicitly underway for products combining these three agents. Market analysis indicates steady demand for contraceptives and iron supplements, with projected growth driven by expanding reproductive health initiatives and iron deficiency treatment needs. Future projections suggest opportunities for combination products, especially in markets prioritizing women’s health and anemia management.

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Are There Ongoing or Upcoming Clinical Trials for This Drug Combination?
There are no registered clinical trials explicitly evaluating a single drug product combining levonorgestrel, ethinyl estradiol, and ferrous fumarate as of early 2023. Most contraceptive products incorporate ethinyl estradiol with progestins like levonorgestrel, aimed at contraception and menstrual regulation. Iron supplementation often accompanies contraceptives in specific formulations targeting anemia, but combination products containing all three agents remain experimental or in early development phases.

Sources:

• ClinicalTrials.gov listings show active trials on combined oral contraceptives and iron supplements but no study matching the triple combination.
• No FDA or EMA approvals cited for products combining these three active ingredients in a single formulation.

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Market Overview and Key Drivers

Contraceptive Market
The global contraceptive market was valued at approximately $18 billion in 2022, with an expected compound annual growth rate (CAGR) near 6% through 2027 (BMI Data, 2022). Oral contraceptives account for nearly 50% of this market, with levonorgestrel-based products dominating sales in North America and Europe. The push for more user-friendly, fewer-pill regimens, and non-invasive options fuels innovation.

Iron Supplement Market
The iron supplement market was valued at around $8 billion in 2022 and is projected to grow at approximately 5% annually through 2027 (Fortune Business Insights, 2022). Iron deficiency anemia remains prevalent, especially in developing countries and among women of reproductive age. Combining iron with contraceptives can improve compliance, reduce pill burden, and address multiple health concerns.

Market Segmentation
Segmenting by region, North America and Europe hold the largest market shares due to higher healthcare spending and regulatory acceptance of combination drugs. Asia-Pacific exhibits high growth potential driven by increasing awareness of women’s health and anemia management.

Regulatory and Reimbursement Trends
Regulatory agencies favor combination pills that improve compliance and reduce pill fatigue. Reimbursement policies in developed markets favor contraceptives and iron supplements coverage, supporting product commercialization.

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Projections for the Market of Combined Agents

Year	Contraceptive Market Value	Iron Supplement Market Value	Combined Market Growth	Key Drivers
2023	$18 billion	$8 billion	N/A	Innovation, women’s health focus
2025	$22 billion	$10 billion	7-8%	Increasing anemia prevalence, contraception awareness
2030	$28 billion	$12 billion	7-8%	Expanded access, product integration

Opportunities
Development of fixed-dose combination products that include levonorgestrel, ethinyl estradiol, and ferrous fumarate could capture unmet needs for women seeking single-pill solutions with contraceptive and anemia management benefits.

Challenges

• Regulatory hurdles for combination products owing to differing safety profiles.
• Market acceptance, as combination of hormonal contraceptives with iron is relatively novel and may require extensive clinical validation.
• Formulation stability, bioavailability, and tolerability.

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Key Takeaways

1. No current clinical trials target a triple combination pill of levonorgestrel, ethinyl estradiol, and ferrous fumarate.
2. The contraceptive market remains dominant in women’s health, with steady growth prospects driven by innovation and demand.
3. The iron supplement segment continues expanding, fueled by anemia prevalence.
4. Combining these agents into a single product could streamline therapy but faces regulatory and commercial barriers.
5. Market potential exists, especially in regions with unmet reproductive health and anemia management needs.

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FAQs

Last updated: February 16, 2026

1. Are there any approved drugs that combine levonorgestrel, ethinyl estradiol, and ferrous fumarate?
No. As of early 2023, no approved combination pills exist that include all three agents. Contraceptives with levonorgestrel and ethinyl estradiol are common, but iron is usually prescribed separately or in multipurpose products.

2. What regulatory challenges could impede development of such combination products?
Separate safety profiles for hormonal contraceptives and iron supplements require extensive clinical testing. Regulatory agencies review for drug-drug interactions, tolerability, and efficacy, which can complicate approval processes for novel combinations.

3. What are the growth drivers for a potential product combining these agents?
The primary drivers include unmet needs in women’s health, the convenience of combined therapy, and increased awareness of anemia associated with reproductive health.

4. In what regions is this market likely to grow fastest?
Asia-Pacific and Latin America exhibit robust growth potential due to rising health awareness, expanded healthcare access, and government initiatives around reproductive health and anemia.

5. What are the main risks in developing combination contraceptives with iron?
Potential risks include adverse drug interactions, side effects related to iron overload, and patient compliance issues related to tolerability.

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Citations

1. BMI Data. "Global Contraceptive Market Report 2022."
2. Fortune Business Insights. "Iron Supplements Market Size, Share & Industry Analysis."
3. ClinicalTrials.gov database. "Listing of Active and Completed Trials (2023)."