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| Sponsor: | Schering-Plough |
|---|---|
| Information provided by: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00511355 |
Purpose
The primary purpose of this study is to evaluate the effects of the combined oral contraceptive NOMAC-E2 on hemostasis, lipids, carbohydrate metabolism, adrenal function, and thyroid function.
| Condition | Intervention | Phase |
|---|---|---|
|
Contraception |
Drug: NOMAC-E2 Drug: Levonorgestrel and Ethinyl Estradiol |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Open-Label, Comparative, Multi -Center Trial to Evaluate the Effects on Hemostasis, Lipids, Carbohydrate Metabolism, and on Adrenal and Thyroid Function of a Monophasic COC Containing 2.5 mg NOMAC and 1.5 mg E2 Compared to a Monophasic COC Containing 150 ug LNG and 30 ug EE |
| Enrollment: | 121 |
| Study Start Date: | September 2006 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Estradiol and Nomegestrol Acetate
|
Drug: NOMAC-E2
Estradiol and Nomegestrol Acetate Tablets, 24 active plus 4 placebo tablets per cycle, 2.5 mg NOMAC and 1.5 mg E2
|
|
2: Active Comparator
Levonorgestrel and Ethinyl Estradiol Tablets
|
Drug: Levonorgestrel and Ethinyl Estradiol
Levonorgestrel and Ethinyl Estradiol Tablets, 150 µg LNG and 30 µg EE, up to 6 cycles of 28 days
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
| Study ID Numbers: | Protocol No. 292004, P05764 |
| Study First Received: | August 2, 2007 |
| Last Updated: | October 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00511355 History of Changes |
| Health Authority: | Finland: Finnish Medicines Agency |
|
Estrogens Contraceptive Agents Contraceptives, Oral Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Ethinyl Estradiol Reproductive Control Agents |
Hormones Estradiol Pharmacologic Actions Contraceptives, Oral, Combined Levonorgestrel Therapeutic Uses Contraceptives, Oral, Synthetic |