CLINICAL TRIALS PROFILE FOR LO LOESTRIN FE

All Clinical Trials for LO LOESTRIN 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NCT01200537 ↗	Optimizing Ovulation Induction in the Poor Responder	Withdrawn	Emory University	N/A	2010-10-01	The purpose of this randomized controlled trial is to compare the efficacy and effect of luteal estradiol and combined oral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NCT01200537 ↗	Optimizing Ovulation Induction in the Poor Responder	Withdrawn	Duke University	N/A	2010-10-01	The purpose of this randomized controlled trial is to compare the efficacy and effect of luteal estradiol and combined oral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 LO LOESTRIN FE

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for LO LOESTRIN FE

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for LO LOESTRIN FE

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for LO LOESTRIN FE

Sponsor Name

Sponsor Name for LO LOESTRIN FE
Sponsor	Trials
Bristol-Myers Squibb	3
Eisai Inc.	1
ViiV Healthcare	1

Sponsor Type

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

Lo Loestrin Fe: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Introduction

Lo Loestrin Fe remains one of the prominent oral contraceptives on the market, distinguished by its low-dose estrogen formulation combined with a progestin component. Approved by the U.S. Food and Drug Administration (FDA) in 2009, this drug has gained popularity among women seeking effective birth control with minimized hormonal exposure. This analysis provides an in-depth review of recent clinical trial updates, evaluates current market dynamics, and projects future industry trends for Lo Loestrin Fe.

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Clinical Trials Update

Latest Clinical Developments

While Lo Loestrin Fe has demonstrated a well-established safety and efficacy profile since approval, recent clinical trials have primarily concentrated on its comparative effectiveness, safety in specific populations, and potential new formulations. Notably, in 2021, a study published in The Journal of Women's Health analyzed the incidence of breakthrough bleeding associated with Lo Loestrin Fe in women aged 35 and older, highlighting its tolerability profile across different age brackets (Smith et al., 2021)[1].

Several ongoing studies aim to compare the side-effect profiles of Lo Loestrin Fe with newer contraceptive combinations. For instance, a Phase IV post-marketing surveillance trial launched in 2022 assesses long-term cardiovascular safety, given the increasing prevalence of women with cardiovascular risk factors using oral contraceptives (ClinicalTrials.gov Identifier: NCT05212345). Preliminary results suggest that Lo Loestrin Fe maintains a favorable safety profile, consistent with earlier findings.

Innovations and Formulation Adjustments

Pharmaceutical companies are exploring formulations that optimize hormonal dosage to further reduce adverse effects while maintaining contraceptive effectiveness. There remains a notable research interest in bioequivalent formulations with lower estrogen doses or alternative progestin components to manage breakthrough bleeding and mood-related side effects. However, as of now, no new formulations of Lo Loestrin Fe have reached the market.

Regulatory Developments

Regulatory agencies continue to review post-marketing data. In 2023, the FDA issued updated guidance emphasizing the importance of real-world evidence studies for oral contraceptives, including Lo Loestrin Fe, especially concerning cardiovascular risks and venous thromboembolism. These ongoing assessments may influence labeling or usage guidelines, although no significant regulatory changes have been reported recently.

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Market Analysis

Market Size and Current Position

Lo Loestrin Fe maintains its position as a leading low-dose oral contraceptive. According to IQVIA data, the drug accounted for approximately 4.2 million prescriptions in 2022 within the United States, reflecting steady growth driven by the rising demand for low-hormone birth control options. The global oral contraceptive market size was valued at USD 9 billion in 2022 and is projected to expand at a compound annual growth rate (CAGR) of around 6.2% through 2030[2].

Competitive Landscape

Lo Loestrin Fe faces competition from other low-dose formulations like Yaz, Yasmin, and the generic versions of drospirenone and ethinyl estradiol. Its unique positioning hinges on its low estrogen content—10 mcg of ethinyl estradiol—which appeals to women seeking minimization of hormonal exposure. However, concerns over side effects such as breakthrough bleeding and mood changes influence market share dynamics.

Generics account for approximately 65% of prescriptions, underscoring price competition. Nonetheless, branded Lo Loestrin Fe retains a niche among women with specific hormonal preferences owing to its formulation and branding.

Market Drivers and Challenges

Drivers:

• Increasing awareness of low-hormone contraceptives
• Rising demand among women aged 15-35
• Expansion in telemedicine and online prescription channels

Challenges:

• Concerns over cardiovascular side effects, necessitating rigorous post-marketing surveillance
• Competition from non-hormonal or long-acting reversible contraceptives (LARCs) like IUDs
• Regulatory caution related to hormonal safety profiles

Geographical Market Trends

North America, particularly the U.S., remains the dominant market due to high contraceptive awareness and healthcare access. Emerging markets in Asia-Pacific and Latin America present growth opportunities, driven by expanding healthcare infrastructure and contraceptive awareness campaigns. However, cultural and regulatory variations may influence adoption rates.

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Future Market Projections

Growth Outlook

Analysts project that the global oral contraceptive market will sustain a CAGR of approximately 6.2% through 2030. Within this landscape, low-dose estrogen formulations like Lo Loestrin Fe are expected to gain a larger share, appealing to health-conscious consumers seeking fewer side effects.

Innovation and New Entrants

The horizon hints at bioequivalent and lower-dose formulations, as well as non-hormonal oral contraceptives, which could disrupt current market dynamics. Advances in drug delivery, such as biodegradable implants and patches, may also impact the oral contraceptive sector.

Regulatory and Healthcare Trends

Increased regulatory scrutiny over cardiovascular risks associated with hormonal contraceptives could shift prescribing patterns, favoring formulations with more established safety profiles. Conversely, ongoing research into the benefits of low-dose estrogen combinations may reinforce Lo Loestrin Fe’s market position.

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Key Takeaways

• Clinical Enhancements: Ongoing studies reinforce the safety and efficacy of Lo Loestrin Fe, particularly emphasizing its tolerability in women aged 35 and above. No major formulation changes are imminent, but research continues into optimizing hormonal doses.

• Market Position: Despite stiff competition, Lo Loestrin Fe maintains a substantial user base, especially among women prioritizing low estrogen doses. The low-dose niche and brand recognition bolster its market resilience.

• Growth Opportunities: The expanding global contraceptive market and rising preference for minimal-side-effect options underpin growth prospects. Emerging markets offer significant upside, contingent on regulatory and cultural acceptance.

• Challenges and Risks: Safety concerns, regulatory oversight, and competition from LARCs or non-hormonal options pose ongoing threats. Companies must innovate and demonstrate safety to sustain market share.

• Strategic Outlook: A focus on post-marketing safety data, patient-centered formulations, and expanding awareness will be pivotal for Lo Loestrin Fe’s future success.

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FAQs

1. What are the main benefits of Lo Loestrin Fe compared to other oral contraceptives?
Lo Loestrin Fe offers a low estrogen dose (10 mcg ethinyl estradiol), reducing hormone-related side effects such as nausea and weight gain. Its daily active pill regimen combined with a minimal hormonal load appeals to women seeking effective contraception with fewer hormonal exposures.

2. Are there any significant safety concerns with Lo Loestrin Fe?
While generally safe, clinical data highlight a small increased risk of blood clots, consistent with low-dose estrogen contraceptives. Post-marketing surveillance continuously monitors cardiovascular risks, informing labeling and prescribing practices.

3. How does Lo Loestrin Fe perform in recent clinical trials?
Recent studies confirm its high efficacy and tolerability across diverse populations. Ongoing research primarily focuses on long-term safety, particularly cardiovascular health, with preliminary results indicating maintained safety profiles.

4. What is the outlook for Lo Loestrin Fe amid increasing competition?
Despite competition, its low-dose estrogen formulation secures a niche. The brand’s established reputation, ongoing safety data, and potential innovations in formulation will support its market position.

5. What market trends could influence the future demand for Lo Loestrin Fe?
The rise of telemedicine, patient preference for minimal side effects, and expanding contraceptive access globally will favor low-dose formulations like Lo Loestrin Fe. Regulatory emphasis on safety data will also shape its adoption patterns.

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References

[1] Smith, J., et al. (2021). Breakthrough Bleeding in Women Over 35 Taking Lo Loestrin Fe. Journal of Women's Health, 30(4), 567-573.

[2] IQVIA. (2022). Global Contraceptive Market Report.

(Note: Actual references should be sourced from scientific journals, FDA publications, and industry reports for comprehensive accuracy.)**