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Last Updated: January 21, 2020

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CLINICAL TRIALS PROFILE FOR NORGESTREL

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505(b)(2) Clinical Trials for Norgestrel

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT03559010 A Study of Oral Contraception Under Simulated OTC Conditions Active, not recruiting 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 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 >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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Norgestrel

Condition Name

Condition Name for Norgestrel
Intervention Trials
Contraception 7
Female Contraception 4
Pharmacokinetics 3
Therapeutic Equivalency 2
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Condition MeSH

Condition MeSH for Norgestrel
Intervention Trials
Colorectal Neoplasms, Hereditary Nonpolyposis 1
Hidradenitis Suppurativa 1
Hidradenitis 1
Endometrial Neoplasms 1
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Clinical Trial Locations for Norgestrel

Trials by Country

Trials by Country for Norgestrel
Location Trials
United States 33
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Trials by US State

Trials by US State for Norgestrel
Location Trials
California 3
Alabama 2
Texas 2
Washington 2
Utah 2
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Clinical Trial Progress for Norgestrel

Clinical Trial Phase

Clinical Trial Phase for Norgestrel
Clinical Trial Phase Trials
Phase 3 2
Phase 2 3
Phase 1 6
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Clinical Trial Status

Clinical Trial Status for Norgestrel
Clinical Trial Phase Trials
Completed 7
Recruiting 2
Terminated 1
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Clinical Trial Sponsors for Norgestrel

Sponsor Name

Sponsor Name for Norgestrel
Sponsor Trials
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. 6
HRA Pharma 3
National Cancer Institute (NCI) 1
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Sponsor Type

Sponsor Type for Norgestrel
Sponsor Trials
Industry 10
Other 2
NIH 1
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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
McKesson
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Mallinckrodt
Merck
Medtronic

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