Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Population Council United States Agency for International Development (USAID) |
---|---|
Information provided by: | Population Council |
ClinicalTrials.gov Identifier: | NCT00213096 |
The purpose of this 3-month (cycle) study was to evaluate the effects of hormonal contraceptives containing a progestin and an estrogen on liver proteins and coagulation factors that are sensitive to estrogen. In this study, a contraceptive vaginal ring containing Nestorone® (a progestin with no androgenic properties) and ethinyl estradiol was compared to an oral contraceptive containing levonorgestrel (an androgenic progestin) and ethinyl estradiol.
Condition | Intervention | Phase |
---|---|---|
Contraception |
Drug: Nestorone/ethinyl estradiol contraceptive vaginal ring; levonorgestrel/ethinyl estradiol oral contraceptive |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety Study |
Official Title: | A Randomized, Open-Label Study Comparing the Effect of a Contraceptive Vaginal Ring Delivering Daily Doses of 150 Micrograms Nestorone and 15 Micrograms Ethinyl Estradiol to an Oral Contraceptive Containing 150 Micrograms of Levonorgestrel and 30 Micrograms of Ethinyl Estradiol Per Tablet on Hepatic Factors Including Coagulation Factors |
Estimated Enrollment: | 50 |
Study Start Date: | March 2003 |
Estimated Study Completion Date: | February 2004 |
The purpose of this 3-month (cycle) study was to evaluate the effects of hormonal contraceptives containing a progestin and an estrogen on liver proteins and coagulation factors that are sensitive to estrogen. In this study, a contraceptive vaginal ring containing Nestorone® (a progestin with no androgenic properties) and ethinyl estradiol was compared to an oral contraceptive containing levonorgestrel (an androgenic progestin) and ethinyl estradiol.
Ages Eligible for Study: | 18 Years to 34 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Netherlands | |
Center for Human Drug Research | |
Leiden, Netherlands |
Principal Investigator: | Regine Sitruk-Ware, MD | Population Council |
Study ID Numbers: | Population Council #323, HRN-A-00-99-00010 |
Study First Received: | September 13, 2005 |
Last Updated: | May 30, 2006 |
ClinicalTrials.gov Identifier: | NCT00213096 |
Health Authority: | United States: Food and Drug Administration |
Contraceptive agents female |
Benzoates ST 1435 Levonorgestrel Estradiol 3-benzoate Estradiol valerate |
Ethinyl Estradiol Estradiol 17 beta-cypionate Polyestradiol phosphate Estradiol |
Estrogens Contraceptive Agents Therapeutic Uses Contraceptives, Oral Physiological Effects of Drugs Contraceptive Agents, Female |
Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptives, Oral, Synthetic Reproductive Control Agents Hormones Pharmacologic Actions |