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Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR LO LOESTRIN FE


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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NCT01200537 ↗ Optimizing Ovulation Induction in the Poor Responder Withdrawn Emory University N/A 2010-10-01 The purpose of this randomized controlled trial is to compare the efficacy and effect of luteal estradiol and combined oral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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Lo Loestrin Fe

Condition Name

Condition Name for Lo Loestrin Fe
Intervention Trials
Healthy Participants 2
Ovulation 1
Pelvic Pain 1
Contraception 1
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Condition MeSH

Condition MeSH for Lo Loestrin Fe
Intervention Trials
Pelvic Pain 1
Headache 1
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Clinical Trial Locations for Lo Loestrin Fe

Trials by Country

Trials by Country for Lo Loestrin Fe
Location Trials
United States 5
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Trials by US State

Trials by US State for Lo Loestrin Fe
Location Trials
California 2
Texas 2
North Carolina 1
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Clinical Trial Progress for Lo Loestrin Fe

Clinical Trial Phase

Clinical Trial Phase for Lo Loestrin Fe
Clinical Trial Phase Trials
Phase 3 1
Phase 1 4
N/A 2
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Clinical Trial Status

Clinical Trial Status for Lo Loestrin Fe
Clinical Trial Phase Trials
Completed 2
Not yet recruiting 2
Unknown status 1
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Clinical Trial Sponsors for Lo Loestrin Fe

Sponsor Name

Sponsor Name for Lo Loestrin Fe
Sponsor Trials
Bristol-Myers Squibb 3
Emory University 1
Duke University 1
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Sponsor Type

Sponsor Type for Lo Loestrin Fe
Sponsor Trials
Industry 6
Other 5
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Lo Loestrin Fe: Clinical Trials, Market Analysis, and Projections

Introduction

Lo Loestrin Fe is a low-dose oral contraceptive (OC) that has garnered significant attention for its unique dosage regimen and efficacy in preventing pregnancy. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials Overview

Efficacy and Safety

The primary clinical trial for Lo Loestrin Fe involved 1,270 women aged 18-35 years, with a body mass index (BMI) of ≤35 kg/m². This multicenter, open-label study evaluated the efficacy of Lo Loestrin Fe over 13 cycles (12,482 twenty-eight-day evaluable cycles). The Pearl Index, a measure of contraceptive efficacy, was calculated to be 2.92 (95% CI: 1.94-4.21), indicating a high level of effectiveness in preventing pregnancy[1][3][5].

The safety profile of Lo Loestrin Fe was also assessed during this trial. No deaths occurred, and the frequency and type of adverse events leading to withdrawals were comparable to other low-dose combined oral contraceptives. Serious adverse reactions included deep vein thrombosis, which is a common risk associated with oral contraceptives[1][3][5].

Adverse Reactions and Bleeding Patterns

Common adverse reactions reported by at least 2% of the participants included nausea/vomiting, headache, and bleeding irregularities. The incidence of unscheduled bleeding and/or spotting was highest during Cycle 2 (53%) and decreased over time, with 36% by Cycle 13. Scheduled (withdrawal) bleeding remained relatively constant throughout the study[4].

Dosage Regimen

Lo Loestrin Fe is distinguished by its ultra-low dose of estrogen, with 10 mcg of ethinyl estradiol per day, which is the lowest daily dose among all available OCs. The regimen consists of:

  • 24 days of tablets containing 10 mcg of ethinyl estradiol and 1 mg of norethindrone acetate
  • 2 days of tablets containing 10 mcg of ethinyl estradiol
  • 2 days of tablets containing ferrous fumarate 75 mg[1][3][5].

This regimen results in 38% less estrogen per month compared to a 20-mcg, 21/7 OC regimen[1].

Market Analysis

Promotional Activities

In 2021, Lo Loestrin Fe was promoted through extensive interactions with healthcare providers. Over 54,940 paid interactions were made across 14,800 physicians, which included sales rep detailing, physician education, and paid speaking engagements. This promotional activity helped in increasing the drug's visibility and adoption among healthcare professionals[2].

Market Reach and Physician Engagement

The promotional mix for Lo Loestrin Fe varied, with a focus on key specialties such as Obstetrics/Gynecology, Nursing, Physician Assistant, and Family Medicine. The depth of coverage within these specialties was significant, with frequent paid meals and speaking engagements for physicians throughout the year[2].

Competitive Landscape

Lo Loestrin Fe competes in the contraception market, which is populated by various oral contraceptives with different dosage regimens. Its unique ultra-low dose of estrogen sets it apart, making it an attractive option for women seeking minimal hormonal exposure while maintaining effective contraception[1][3][5].

Projections and Future Outlook

Market Growth

Given its unique selling points, Lo Loestrin Fe is expected to continue growing in the market. The increasing awareness and preference for low-dose hormonal contraceptives among women and healthcare providers are likely to drive its adoption. Additionally, the extensive promotional activities and strong engagement with key healthcare specialties will further bolster its market presence[2].

Patient Preferences

Women may potentially take oral contraceptives for many years during their reproductive lives, and the preference for lower doses of estrogen is on the rise. Lo Loestrin Fe, with its ultra-low dose, is well-positioned to meet this demand, potentially increasing its market share in the coming years[1].

Regulatory and Safety Considerations

The safety profile of Lo Loestrin Fe, as demonstrated in clinical trials, is acceptable and comparable to other low-dose OCs. No postmarketing risk evaluation and mitigation strategies have been recommended, and standard post-marketing surveillance is in place. This suggests a stable regulatory environment for the drug, which is crucial for long-term market success[3][5].

Key Takeaways

  • Efficacy and Safety: Lo Loestrin Fe has a high efficacy in preventing pregnancy, with a Pearl Index of 2.92, and a safety profile comparable to other low-dose OCs.
  • Unique Dosage Regimen: It features the lowest daily dose of ethinyl estradiol (10 mcg) and a 24/2/2 regimen, resulting in 38% less estrogen per month.
  • Market Presence: Extensive promotional activities and strong engagement with healthcare providers have contributed to its market reach.
  • Future Outlook: Expected to grow due to increasing preference for low-dose hormonal contraceptives and its unique selling points.

FAQs

Q: What is the unique dosage regimen of Lo Loestrin Fe?

A: Lo Loestrin Fe consists of 24 days of tablets containing 10 mcg of ethinyl estradiol and 1 mg of norethindrone acetate, followed by 2 days of tablets containing 10 mcg of ethinyl estradiol, and then 2 days of tablets containing ferrous fumarate 75 mg[1][3][5].

Q: How effective is Lo Loestrin Fe in preventing pregnancy?

A: Lo Loestrin Fe has a Pearl Index of 2.92 (95% CI: 1.94-4.21), indicating a high level of effectiveness in preventing pregnancy[1][3][5].

Q: What are the common adverse reactions associated with Lo Loestrin Fe?

A: Common adverse reactions include nausea/vomiting, headache, and bleeding irregularities[4].

Q: How does the promotional strategy of Lo Loestrin Fe impact its market presence?

A: The extensive promotional activities, including sales rep detailing, physician education, and paid speaking engagements, have significantly increased its visibility and adoption among healthcare professionals[2].

Q: What sets Lo Loestrin Fe apart from other oral contraceptives?

A: Lo Loestrin Fe has the lowest daily dose of ethinyl estradiol (10 mcg) among all available OCs, making it an attractive option for women seeking minimal hormonal exposure[1].

Sources

  1. For Healthcare Providers - Why Lo Loestrin® Fe? - hcp.loloestrin.com
  2. Lo Loestrin Fe 2021 report - MDDetails
  3. Lo Loestrin Fe - accessdata.fda.gov
  4. Lo Loestrin Fe - accessdata.fda.gov
  5. 022501Orig1s000 - accessdata.fda.gov

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