You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: February 16, 2025

CLINICAL TRIALS PROFILE FOR LOESTRIN 24 FE


✉ Email this page to a colleague

« Back to Dashboard


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NCT01200537 ↗ Optimizing Ovulation Induction in the Poor Responder Withdrawn Emory University N/A 2010-10-01 The purpose of this randomized controlled trial is to compare the efficacy and effect of luteal estradiol and combined oral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

Clinical Trial Conditions for Loestrin 24 Fe

Condition Name

Condition Name for Loestrin 24 Fe
Intervention Trials
Healthy Participants 2
Contraception 1
Emotional 1
Headaches 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Loestrin 24 Fe
Intervention Trials
Pelvic Pain 1
Headache 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Loestrin 24 Fe

Trials by Country

Trials by Country for Loestrin 24 Fe
Location Trials
United States 5
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Loestrin 24 Fe
Location Trials
California 2
Texas 2
North Carolina 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Loestrin 24 Fe

Clinical Trial Phase

Clinical Trial Phase for Loestrin 24 Fe
Clinical Trial Phase Trials
Phase 3 1
Phase 1 4
N/A 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Loestrin 24 Fe
Clinical Trial Phase Trials
Completed 2
Not yet recruiting 2
Active, not recruiting 1
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Loestrin 24 Fe

Sponsor Name

Sponsor Name for Loestrin 24 Fe
Sponsor Trials
Bristol-Myers Squibb 3
Emory University 1
Duke University 1
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Loestrin 24 Fe
Sponsor Trials
Industry 6
Other 5
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Loestrin 24 Fe: Clinical Trials, Market Analysis, and Projections

Overview of Loestrin 24 Fe

Loestrin 24 Fe is a low-dose progestin/estrogen combination oral contraceptive, manufactured and marketed by Warner Chilcott. It contains norethindrone acetate and ethinyl estradiol, and is designed to provide effective contraception with a reduced risk of certain side effects associated with higher dose contraceptives[4].

Clinical Trial Experience

Safety and Efficacy

The safety and efficacy of Loestrin 24 Fe were evaluated in a significant clinical trial involving 743 healthy, non-pregnant women aged 18 to 45 years. This open-label, randomized, active-controlled, multicenter trial followed subjects for up to six 28-day cycles, providing a total of 3,823 treatment-cycles of exposure.

  • Adverse Reactions: The most common adverse reactions reported by at least 2% of the participants included headache (6.3%), vaginal candidiasis (6.1%), nausea (4.6%), menstrual cramps (4.4%), breast tenderness (3.4%), mood changes (including mood swings and depression), bacterial vaginitis, acne, and weight gain[1][4].
  • Withdrawal Rates: 46 women (6.2%) withdrew from the trial due to adverse events, with the most common reasons being abnormal bleeding, nausea, mood changes, and menstrual cramps[1].
  • Pregnancy Rates: The Pearl Index for Loestrin 24 Fe was calculated to be 1.82, indicating a low pregnancy rate among users. Only 5 on-treatment pregnancies occurred in 3,565 treatment cycles where no backup contraception was used[4].

Pharmacokinetics

The pharmacokinetics of Loestrin 24 Fe were studied in 17 healthy female volunteers. The results showed that following multiple-dose administration, the mean maximum concentrations of norethindrone and ethinyl estradiol increased by 95% and 27%, respectively, compared to single-dose administration. Steady-state levels were reached by Day 17 for norethindrone and Day 13 for ethinyl estradiol[4].

Market Analysis

Market Position

Loestrin 24 Fe is a branded product with no current generic competitors in the market. Warner Chilcott holds the market exclusivity for this drug, although Actavis is expected to be the first to introduce a generic version once the patents expire[5].

Market Competition

The proposed acquisition between Warner Chilcott and Actavis raised anticompetitive concerns, as it would reduce the number of suppliers in the relevant markets. The FTC intervened, requiring Actavis to divest certain rights and assets related to generic versions of Loestrin 24 Fe to Amneal, ensuring continued competition in the market[5].

Sales Assessment

Historical sales data and forecasted sales figures for Loestrin 24 Fe indicate a stable market presence. The "Loestrin 24 Fe Drug Insight, 2019" report provides detailed sales assessments, including historical global sales and forecasted sales from 2019 to 2021. This report is crucial for understanding the drug's market performance and future growth potential[2].

Market Projections

Forecasted Sales

The market analysis suggests that Loestrin 24 Fe will continue to perform well in the contraceptive market. The forecasted sales figures from 2019 to 2021 indicate a steady demand for the product, driven by its efficacy and safety profile. However, the entry of generic competitors, once the patents expire, may impact future sales[2].

Emerging Therapies and Competition

The report also highlights emerging therapies and potential competitors in the same space. Understanding these factors is essential for planning developmental timelines and API procurement strategies. The SWOT analysis provided in the report helps in identifying opportunities and challenges in the market, enabling better strategic planning[2].

Regulatory Milestones

FDA Approval and Postmarket Surveillance

Loestrin 24 Fe has undergone rigorous clinical trials and has been approved by the FDA. The primary clinical trial demonstrated an acceptable safety profile with no deaths or new safety concerns. Standard post-marketing surveillance was recommended to monitor any adverse events, but no specific risk management steps were required[3][4].

Patent Expiry and Exclusivity

The patent expiry timeline and exclusivity details are critical for understanding the market exclusivity period of Loestrin 24 Fe. This information helps in planning for generic entry and competition in the future[2].

Conclusion

Loestrin 24 Fe is a well-established low-dose oral contraceptive with a proven safety and efficacy profile. The clinical trials have demonstrated its effectiveness in preventing pregnancy and its manageable side effect profile. Market analysis indicates a strong market position, although the entry of generic competitors is anticipated. Understanding the market dynamics, regulatory milestones, and emerging therapies is crucial for both the manufacturer and potential generic entrants.

Key Takeaways

  • Clinical Trials: Loestrin 24 Fe has been evaluated in significant clinical trials, showing a favorable safety and efficacy profile.
  • Adverse Reactions: Common adverse reactions include headache, vaginal candidiasis, nausea, and menstrual cramps.
  • Market Position: Currently, Loestrin 24 Fe is a branded product without generic competitors.
  • Market Projections: Forecasted sales indicate steady demand, but generic competition is expected once patents expire.
  • Regulatory Milestones: FDA-approved with standard post-marketing surveillance recommended.
  • Emerging Therapies: Understanding emerging therapies and competitors is essential for strategic planning.

FAQs

Q1: What are the common adverse reactions associated with Loestrin 24 Fe?

The most common adverse reactions include headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, mood changes, bacterial vaginitis, acne, and weight gain[1][4].

Q2: How effective is Loestrin 24 Fe in preventing pregnancy?

Loestrin 24 Fe has a Pearl Index of 1.82, indicating a low pregnancy rate among users. Only 5 on-treatment pregnancies occurred in 3,565 treatment cycles where no backup contraception was used[4].

Q3: Is Loestrin 24 Fe available in generic form?

Currently, no generic version of Loestrin 24 Fe is available in the market. However, Actavis is expected to be the first to introduce a generic version once the patents expire[5].

Q4: What is the significance of the FTC intervention in the acquisition between Warner Chilcott and Actavis?

The FTC intervention ensured that Actavis would divest certain rights and assets related to generic versions of Loestrin 24 Fe to Amneal, maintaining competition in the market and preventing anticompetitive effects[5].

Q5: How does Loestrin 24 Fe compare to other low-dose oral contraceptives in terms of pharmacokinetics?

Loestrin 24 Fe shows increased mean maximum concentrations and exposures of norethindrone and ethinyl estradiol following multiple-dose administration, with steady-state levels reached by Day 17 and Day 13, respectively[4].

Sources

  1. RxList: Loestrin 24 Fe (Norethindrone Acetate-Ethinyl Estradiol) - RxList
  2. BusinessWire: Global Loestrin 24 Fe- Drug Insights, 2019-2021
  3. FDA: 022501Orig1s000MedR.pdf
  4. FDA: Loestrin 24 Fe (norethindrone acetate and ethinyl estradiol tablets) - accessdata.fda.gov
  5. FTC: analysis of agreement containing consent orders - ftc.gov

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.