CLINICAL TRIALS PROFILE FOR ETHINYL ESTRADIOL AND NORELGESTROMIN
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All Clinical Trials for Ethinyl Estradiol And Norelgestromin
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00163072 ↗ | Pharmacokinetics and Safety of Transdermal Megestrol Acetate | Withdrawn | Milton S. Hershey Medical Center | Phase 4 | 2005-10-01 | Rationale: Megestrol acetate (Megace®) is a progestin analog that is FDA approved for the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 | 2002-08-01 | 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 | 2004-05-01 | 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 | 2004-04-01 | 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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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Clinical Trial Sponsors for Ethinyl Estradiol And Norelgestromin
Sponsor Name
| Sponsor Name for Ethinyl Estradiol And Norelgestromin | |
| Sponsor | Trials |
| Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | 7 |
| Janssen Research & Development, LLC | 3 |
| University of Washington | 1 |
| [disabled in preview] | 1 |
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