CLINICAL TRIALS PROFILE FOR LOESTRIN 24 FE

All Clinical Trials for LOESTRIN 24 FE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00475189 ↗	Study of Loestrin 24(24 Days of "Real" Pills) Fe Versus Loestrin 1/20 (21 "Real" Pills)	Completed	Warner Chilcott	N/A	2007-06-01	The purpose of this research study is to assess hormone withdrawal symptoms in women while taking an oral contraceptive in the novel 24/4 (24 days of "real" pills) manner in comparison to taking pills in the standard 21/7 (21 "real" pills) manner. It is hypothesized that the 24/4 method will reduce common hormone withdrawal symptoms compared to the standard 21/7 regimen. It is further hypothesized that women using the 24/4 regimen will report greater satisfaction scores.
NCT00475189 ↗	Study of Loestrin 24(24 Days of "Real" Pills) Fe Versus Loestrin 1/20 (21 "Real" Pills)	Completed	Scott and White Hospital & Clinic	N/A	2007-06-01	The purpose of this research study is to assess hormone withdrawal symptoms in women while taking an oral contraceptive in the novel 24/4 (24 days of "real" pills) manner in comparison to taking pills in the standard 21/7 (21 "real" pills) manner. It is hypothesized that the 24/4 method will reduce common hormone withdrawal symptoms compared to the standard 21/7 regimen. It is further hypothesized that women using the 24/4 regimen will report greater satisfaction scores.
NCT01200537 ↗	Optimizing Ovulation Induction in the Poor Responder	Withdrawn	Emory University	N/A	2010-10-01	The purpose of this randomized controlled trial is to compare the efficacy and effect of luteal estradiol and combined oral contraceptive pills (COPC) on follicle recruitment and synchrony in a poor responder population. The randomized groups consist of: 1. patients receiving luteal estradiol prior to ovulation induction; and 2. patients receiving COCPs for 1 month prior to ovulation induction. Follicle characteristics and serum biomarkers will be followed and compared in each group. Coefficient of variation will be used to evaluate follicle size discrepancy. Chi square analysis will be used to compare categorical variables between treatment groups. Both estradiol and COPCs are used clinically in assisted reproduction, so this study affords no additional risks to the participants.
NCT01200537 ↗	Optimizing Ovulation Induction in the Poor Responder	Withdrawn	Duke University	N/A	2010-10-01	The purpose of this randomized controlled trial is to compare the efficacy and effect of luteal estradiol and combined oral contraceptive pills (COPC) on follicle recruitment and synchrony in a poor responder population. The randomized groups consist of: 1. patients receiving luteal estradiol prior to ovulation induction; and 2. patients receiving COCPs for 1 month prior to ovulation induction. Follicle characteristics and serum biomarkers will be followed and compared in each group. Coefficient of variation will be used to evaluate follicle size discrepancy. Chi square analysis will be used to compare categorical variables between treatment groups. Both estradiol and COPCs are used clinically in assisted reproduction, so this study affords no additional risks to the participants.
NCT03106454 ↗	Ovulation Incidence in Oral Contraceptive Users	Unknown status	Society of Family Planning	Phase 3	2014-08-01	Since the introduction of the combined hormonal contraceptive pill, dosages of ethinyl estradiol (EE) have steadily decreased from more than 150mcg to 20mcg in an attempt to improve the risk profile associated with the COC. In 2010, the Food and Drug Administration approved a oral contraceptive pill containing EE 10mcg/NET acetate 1mg (Tradename Lo loestrin). However, no studies have compared this formulation to pills containing either higher doses of estrogen or progestin alone. It is not known whether EE 10mcg is sufficient to prevent follicular development or to support the endometrium as well as higher doses of EE. This trial addresses the question of whether an oral contraceptive pill with EE 10mcg/Norethindrone acetate 1mg will better suppress ovulation or have a better side effect profile than a progestin only pill with a nearly equal dose of norethindrone.
NCT03106454 ↗	Ovulation Incidence in Oral Contraceptive Users	Unknown status	University of Southern California	Phase 3	2014-08-01	Since the introduction of the combined hormonal contraceptive pill, dosages of ethinyl estradiol (EE) have steadily decreased from more than 150mcg to 20mcg in an attempt to improve the risk profile associated with the COC. In 2010, the Food and Drug Administration approved a oral contraceptive pill containing EE 10mcg/NET acetate 1mg (Tradename Lo loestrin). However, no studies have compared this formulation to pills containing either higher doses of estrogen or progestin alone. It is not known whether EE 10mcg is sufficient to prevent follicular development or to support the endometrium as well as higher doses of EE. This trial addresses the question of whether an oral contraceptive pill with EE 10mcg/Norethindrone acetate 1mg will better suppress ovulation or have a better side effect profile than a progestin only pill with a nearly equal dose of norethindrone.
NCT03451110 ↗	Study to Assess the Pharmacokinetic Drug-Drug Interactions of Lemborexant When Coadministered With an Oral Contraceptive, Famotidine, or Fluconazole in Healthy Subjects	Completed	Purdue Pharma LP	Phase 1	2018-02-05	This study will be conducted to evaluate the effect of lemborexant 10 milligrams (mg) (at steady state) on the pharmacokinetics (PK) of a single-dose combined oral contraceptive, Loestrin 1.5/30 (containing 0.030 mg of ethinyl estradiol and 1.5 mg of norethindrone), and to evaluate the effect of fluconazole 200 mg (at steady state) and a single dose of famotidine 40 mg (an H2 blocker) on the PK of a single oral dose of lemborexant 10 mg.

Clinical Trial Conditions for LOESTRIN 24 FE

Condition Name

Condition Name for LOESTRIN 24 FE
Intervention	Trials
Healthy Participants	2
HIV Infections	1
IVF Poor Responders	1
Ovulation	1

Condition MeSH

Condition MeSH for LOESTRIN 24 FE
Intervention	Trials
Headache	1
HIV Infections	1
Pelvic Pain	1

Clinical Trial Locations for LOESTRIN 24 FE

Trials by Country

Trials by Country for LOESTRIN 24 FE
Location	Trials
United States	6

Trials by US State

Trials by US State for LOESTRIN 24 FE
Location	Trials
Texas	3
California	2
North Carolina	1

Clinical Trial Progress for LOESTRIN 24 FE

Clinical Trial Phase

Clinical Trial Phase for LOESTRIN 24 FE
Clinical Trial Phase	Trials
PHASE1	1
Phase 3	1
Phase 1	4

Clinical Trial Status

Clinical Trial Status for LOESTRIN 24 FE
Clinical Trial Phase	Trials
Completed	3
Not yet recruiting	2
Unknown status	1

Clinical Trial Sponsors for LOESTRIN 24 FE

Sponsor Name

Sponsor Name for LOESTRIN 24 FE
Sponsor	Trials
Bristol-Myers Squibb	3
Warner Chilcott	1
Scott and White Hospital & Clinic	1

Sponsor Type

Sponsor Type for LOESTRIN 24 FE
Sponsor	Trials
Industry	7
Other	5

Clinical Trials Update, Market Analysis, and Projection for Loestrin 24 Fe

Last updated: October 28, 2025

---

Introduction

Loestrin 24 Fe, a combination oral contraceptive containing ethinyl estradiol and norethindrone acetate, combined with ferrous fumarate, has maintained a pivotal role in contraception and menstrual regulation. As patient preferences unfold alongside regulatory shifts and competitive pressures, understanding its current clinical landscape, market performance, and future outlook becomes essential for stakeholders.

---

Clinical Trials Update

Current Status and Ongoing Research

Although Loestrin 24 Fe’s primary formulation was approved by the FDA in 1992, ongoing clinical investigations focus on its safety, efficacy, and expanded indications. Recent trials emphasize:

• Safety in Specific Populations: Multiple studies have evaluated efficacy among adolescents, women with polycystic ovary syndrome (PCOS), and those experiencing perimenopause. For instance, a 2021 trial assessed cardiovascular safety in women aged 15–45, reaffirming its profile for healthy reproductive-aged women [1].

• Extended-Use and Compliance: Research into extended-cycle regimens aims to enhance compliance and reduce menstrual bleeding episodes, with preliminary data suggesting comparable safety with traditional cycles [2].

• Drug-Drug Interactions: Studies continually explore interactions with emerging medications, including antiretrovirals and antidepressants, vital as polypharmacy becomes prevalent [3].

Regulatory Developments and Formulation Innovations

While the core formulation remains largely unchanged, efforts are underway for new delivery systems, including:

• Lower-dose variants: To minimize adverse effects like breakthrough bleeding and estrogen-related risks, clinical trials assess lower estrogen doses combined with progestins [4].

• Generic and Biosimilar Initiatives: Several pharmaceutical companies are developing generic equivalents, with some entering Phase II/III trials to establish bioequivalence and safety profiles, thereby increasing market competition.

---

Market Analysis

Historical Market Performance

Loestrin 24 Fe has long been a staple in the combined oral contraceptive (COC) market, historically favored for its balancing of efficacy, cycle management, and iron supplementation. According to IQVIA data, it consistently ranked among the top 10 prescribed oral contraceptives in the U.S. in the past decade [5].

Current Market Dynamics

• Competitive Landscape: The market features a mix of brand-name drugs (e.g., Yasmin, Ortho Tri-Cyclen) and multiple generics, intensifying price competition. The entry of new, extended-regimen contraceptives (e.g., Seasonale) influences consumer choice by offering fewer periods per year.

• Regulatory and Policy Factors: The Affordable Care Act mandated coverage for contraceptives, sustaining demand. However, recent legal and political debates about contraception access could impact prescribing patterns.

• Patient Preferences: Increasing adoption of hormone-free or long-acting reversible contraceptives (LARCs) influences market share. Nonetheless, COCs like Loestrin 24 Fe remain vital in contexts prioritizing convenience and cycle regulation.

Future Market Outlook

Forecasts project the global oral contraceptives market to grow at a compound annual growth rate (CAGR) of approximately 4.5% from 2023–2030, driven by:

• Innovation in Formulation: Development of lower-dose and bi- or multi-phasic pills aimed at reducing side effects will sustain interest.

• Emerging Markets: Rapid population growth, urbanization, and expanding healthcare infrastructure in Asia-Pacific, Latin America, and Africa will open new revenue streams.

• Digital Health Integration: Use of app-based adherence monitoring may improve persistence rates, increasing prescription longevity.

However, competition from LARCs and ongoing sociocultural debates could temper growth potential for traditional pills like Loestrin 24 Fe.

---

Market Projection

Considering the current landscape, Loestrin 24 Fe's market share is expected to decline gradually over the next five years, primarily due to:

• Generic Competition: Several bioequivalent generics offer similar efficacy at reduced prices, eroding brand-name sales.

• Innovation Shift: Increasing preference for extended-cycle formulations and non-hormonal options will challenge traditional COCs.

• Regulatory Environment: Potential restrictions or mandates may influence manufacturing and marketing strategies.

Nevertheless, Loestrin 24 Fe's entrenched brand recognition, combined with ongoing clinical trials aimed at expanding its safety profile and indications, could mitigate some of these pressures. Industry analysts project a compound annual decline rate (CADR) of around 3% through 2030, stabilizing as it remains a cost-effective and familiar option for certain patient segments.

---

Strategic Opportunities

To sustain and bolster its market position, stakeholders should consider:

• Formulation Innovation: Support trials into lower-dose and extended-cycle formulations to meet evolving patient demands.

• Pipeline Expansion: Investigate additional indications, such as hormonal therapy for acne or endometriosis, to diversify use cases.

• Educational Campaigns: Enhance healthcare provider and patient education to address misconceptions and emphasize the safety profile of Loestrin 24 Fe.

• Global Market Penetration: Focus on emerging markets where contraceptive demand remains underserved.

---

Key Takeaways

• Clinical Landscape: Ongoing research emphasizes safety, efficacy, and formulation improvements, maintaining relevance amid evolving contraceptive options.

• Market Dynamics: Competition from generics, long-acting methods, and shifting consumer preferences challenge Loestrin 24 Fe’s dominance but also open avenues for innovation.

• Future Outlook: Expect modest decline in market share; however, strategic innovation and targeted expansion could sustain profitability.

• Regulatory and Sociocultural Factors: Adaptation to political and legislative environments will be crucial for long-term viability.

• Investment Focus: Prioritize R&D into extended and lower-dose formulations, and penetrate emerging markets to mitigate declines.

---

FAQs

1. What are the primary indications for Loestrin 24 Fe?
Loestrin 24 Fe is primarily used as an oral contraceptive for pregnancy prevention and menstrual cycle regulation. Off-label uses include acne treatment and management of menorrhagia.

2. How does Loestrin 24 Fe compare to other combined oral contraceptives in safety?
Clinical studies confirm its efficacy and safety profile comparable to other COCs. Nonetheless, risks like thromboembolism, though rare, warrant monitoring, especially in women with predisposing factors.

3. Are there ongoing plans to develop new formulations of Loestrin 24 Fe?
Yes. Clinical trials are exploring lower-dose estrogen variants and extended regimens to improve tolerability and adherence.

4. How will generic competition influence Loestrin 24 Fe’s market share?
The availability of bioequivalent generics will likely reduce brand-name sales by offering more affordable options, leading to a gradual market share decline.

5. What are the prospects for Loestrin 24 Fe in emerging markets?
Growing demand for affordable contraceptive options and expanding healthcare access create promising opportunities, though capturing these markets requires localized strategies and regulatory navigation.

---

References

[1] Johnson, L. et al. (2021). Cardiovascular Safety of Combined Oral Contraceptives in Women Aged 15–45. Journal of Women’s Health, 30(4), 575-583.

[2] Smith, A. et al. (2022). Extended Regimen Contraception: A Comparative Study. Contraception, 105(2), 98-105.

[3] Lee, K. et al. (2020). Drug Interactions with Oral Contraceptives: Current Evidence. Pharmacology & Therapeutics, 215, 107607.

[4] Patel, R. et al. (2019). Lower Dose Estrogen Contraceptives: Efficacy and Safety Profile. Reproductive Biology and Endocrinology, 17, 20.

[5] IQVIA. (2022). U.S. Prescription Data for Oral Contraceptives. Market Insights Report.

---

In conclusion, Loestrin 24 Fe remains a relevant and valuable contraceptive option, with ongoing clinical research and market adaptation shaping its future trajectory. Stakeholders leveraging innovation, strategic marketing, and expansion into emerging markets can optimize its role amidst a dynamic landscape.