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. |
| 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. |
| NCT00709189 ↗ | Bioequivalence Study of the Oral Contraceptive Tablet Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) With or Without Folic Acid in Healthy Women. | Completed | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Phase 1 | 2005-05-01 | The purpose of the study is to determine the bioequivalence of NGM and EE in 2 formulations of 250 mcg NGM/35 mcg EE, 1 without folic acid and 1 containing 400 mcg folic acid. The pharmacokinetics of blood folate from the formulation of 250 mcg NGM/35 mcg EE containing 400 mcg folic acid and from 400 mcg folic acid administered alone is characterized. |
| NCT00709644 ↗ | Bioequivalence Study of the Oral Contraceptive (OC) Tablet Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) With or Without Folic Acid in Healthy Women. | Completed | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Phase 1 | 2005-04-01 | The purpose of the study is to determine the bioequivalence of Norgestimate (NGM) and Ethinyl Estradiol (EE) in 2 formulations of 250 mcg NGM/25 mcg EE, 1 without folic acid and 1 containing 400 mcg folic acid. The pharmacokinetics of blood folate from the formulation of 250 mcg NGM/25 mcg EE containing 400 mcg folic acid and from 400 mcg folic acid administered alone is characterized. |
| NCT00709982 ↗ | A Drug Interaction Study of Folic Acid and Oral Contraceptive Tablets Containing Norgestimate (NGM) /Ethinyl Estradiol (EE) in Healthy Women. | Completed | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Phase 1 | 2005-05-01 | The purpose of the study is to assess the effect of folic acid administration on the blood level and the breakdown products of OC study drug (250 mcg norgestimate[NGM]/35 mcg Ethinyl Estradiol [EE]) tablets. The effect of study drug tablet intake on the blood level of folic acid is also determined. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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