CLINICAL TRIALS PROFILE FOR NORGESTREL
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505(b)(2) Clinical Trials for NORGESTREL
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| OTC | NCT03559010 ↗ | A Study of Oral Contraception Under Simulated OTC Conditions | Terminated | HRA Pharma | Phase 3 | 2018-04-27 | This study is designed to assess whether consumers select and use norgestrel 0.075 mg, a progestin only pill for contraception, in a manner consistent with the OTC package directions in an Over-the-Counter (OTC)-like setting. |
| OTC | NCT04112095 ↗ | Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use | Active, not recruiting | HRA Pharma | Phase 3 | 2019-09-06 | This study is designed to assess whether consumers select and use norgestrel 0.075 mg, a progestin only pill for contraception, in a manner consistent with the OTC package directions in an Over-the-Counter (OTC)-like setting. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for NORGESTREL
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00033358 ↗ | Hormone Therapy in Preventing Endometrial Cancer in Patients With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer | Completed | National Cancer Institute (NCI) | Phase 2 | 2002-02-01 | Randomized phase II trial to compare two different hormone therapy regimens in preventing endometrial cancer in women who have a genetic risk for hereditary nonpolyposis colon cancer. Hormone therapy may prevent the development of endometrial cancer in women with a genetic risk for hereditary nonpolyposis colon cancer. It is not yet known which hormone therapy regimen is more effective in preventing endometrial cancer. |
| 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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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