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Generated: December 14, 2018

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CLINICAL TRIALS PROFILE FOR ETHINYL ESTRADIOL; NORELGESTROMIN

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Clinical Trials for Ethinyl Estradiol; Norelgestromin

Trial ID Title Status Sponsor Phase Summary
NCT00163072 Pharmacokinetics and Safety of Transdermal Megestrol Acetate Withdrawn Milton S. Hershey Medical Center Phase 4 Rationale: Megestrol acetate (Megace®) is a progestin analog that is FDA approved for the palliative treatment of breast and endometrial carcinoma. It is also commonly used as an appetite stimulant, particularly in HIV and cancer patients with poor appetite from their primary disease and/or their therapy. Megace is well absorbed orally, however, many patients, particularly younger ones have difficulty taking oral medications. Transdermal progestins are available and are FDA approved. For example, Ortho EvraTM is a transdermal contraceptive patch containing an estrogen (ethinyl estradiol) and a progestin (norelgestromin). Key Objectives: Compare the pharmacokinetics of orally administered vs. transdermal Megace and determine if there are any local side effects of the transdermal route.
NCT00254865 A Comparative Pharmacokinetic Study of ORTHO EVRA (a Transdermal Contraceptive Patch) and CILEST (an Oral Contraceptive) in Healthy Female Volunteers Completed Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Phase 1 The objective of this study is to compare the levels of the hormones norelgestromin, norgestrel, and ethinyl estradiol in the bloodstream of healthy female volunteers administered ORTHO EVRA® (a transdermal contraceptive patch) and CILEST® (an oral contraceptive). The open-label treatment phase of the study consists of two 28-day cycles of one treatment, a washout period of 28 days, and crossover to two 28-day cycles of the other treatment.
NCT00258063 A Study to Evaluate the Exposure of Norelgestromin and Ethinyl Estradiol From Commercial Lots of EVRA (a Transdermal Contraceptive Patch Manufactured by LOHMANN Therapie-Systeme) and CILEST (an Oral Contraceptive) Completed Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Phase 1 The objective of this study is to estimate exposure to the hormones norelgestromin, norgestrel, and ethinyl estradiol in healthy female volunteers across multiple commercial lots of EVRA® (a transdermal contraceptive patch manufactured by LOHMANN Therapie-Systeme), to compare these data to exposure data from one clinical lot, and to compare these data to exposure data from a commercially available oral contraceptive.
NCT00258076 A Study to Evaluate the Hormone Exposure From Multiple Commercial Lots of ORTHO EVRA (a Transdermal Contraceptive Patch) Completed Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Phase 1 The objective of this study is to estimate the exposure to the hormones norelgestromin, norgestrel, and ethinyl estradiol in the bloodstream of healthy female volunteers across multiple commercial lots of ORTHO EVRA® (a transdermal contraceptive patch) and to compare these data to historical hormonal exposure data from one ORTHO EVRA® clinical development lot.
NCT00261482 Evaluation of Women's Experience With EVRA (Norelgestromin + Ethinyl Estradiol) Transdermal Contraceptive Patch Compared With Previous Methods of Contraception. Completed Janssen Pharmaceutica N.V., Belgium Phase 4 The purpose of the study is to evaluate user experience with the EVRA® Contraceptive Transdermal Patch; specifically, user satisfaction with the EVRA® Patch, and if applicable, user preference of the EVRA® Patch compared with the previous method of contraception. The study also evaluates contraceptive efficacy, safety and user compliance.
NCT00320580 An Open-Label Study to Compare the Bleeding Profile of Norelgestromin/Ethinyl Estradiol in an Extended Regimen to Norelgestromin/Ethinyl Estradiol Given in a Traditional Regimen Completed McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. Phase 2 The purpose of this study is to compare the bleeding profile of norelgestromin/ethinyl estradiol given in an extended continuous regimen to norelgestromin/ethinyl estradiol given in a traditional cyclic regimen
NCT00331071 Postmarketing Study of ORTHO EVRA (Norelgestromin and Ethinyl Estradiol Contraceptive Patch) in Relation to Venous Thromboembolism (Blood Clots), Stroke and Heart Attacks Completed Boston Collaborative Drug Surveillance Program N/A The purpose of the study is to assess the occurrence of venous thromboembolism (blood clots), stroke, and heart attack in current users of ORTHO EVRA compared to current users of norgestimate-containing oral contraceptives with 35 mcg ethinyl estradiol with special attention to duration of use. The study uses data from the PharMetrics Patient-Centric Database and MarketScan database, which are US medical claims databases.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Ethinyl Estradiol; Norelgestromin

Condition Name

Condition Name for Ethinyl Estradiol; Norelgestromin
Intervention Trials
Contraception 8
Female Contraception 8
Healthy 2
Venous Thrombosis 1
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Condition MeSH

Condition MeSH for Ethinyl Estradiol; Norelgestromin
Intervention Trials
Thromboembolism 2
Venous Thromboembolism 2
Hepatitis C 1
Metrorrhagia 1
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Clinical Trial Locations for Ethinyl Estradiol; Norelgestromin

Trials by Country

Trials by Country for Ethinyl Estradiol; Norelgestromin
Location Trials
United States 5
Netherlands 1
Belgium 1
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Trials by US State

Trials by US State for Ethinyl Estradiol; Norelgestromin
Location Trials
Massachusetts 1
New Jersey 1
Kansas 1
Washington 1
Pennsylvania 1
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Clinical Trial Progress for Ethinyl Estradiol; Norelgestromin

Clinical Trial Phase

Clinical Trial Phase for Ethinyl Estradiol; Norelgestromin
Clinical Trial Phase Trials
Phase 4 5
Phase 2 2
Phase 1 7
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Clinical Trial Status

Clinical Trial Status for Ethinyl Estradiol; Norelgestromin
Clinical Trial Phase Trials
Completed 13
Unknown status 1
Active, not recruiting 1
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Clinical Trial Sponsors for Ethinyl Estradiol; Norelgestromin

Sponsor Name

Sponsor Name for Ethinyl Estradiol; Norelgestromin
Sponsor Trials
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. 7
Janssen Research & Development, LLC 2
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. 1
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Sponsor Type

Sponsor Type for Ethinyl Estradiol; Norelgestromin
Sponsor Trials
Industry 14
Other 6
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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Healthtrust
Baxter
Teva
Accenture
UBS
Cerilliant
Cantor Fitzgerald
Argus Health

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