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| Sponsor: | Schering-Plough |
|---|---|
| Information provided by: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00511199 |
Purpose
The primary purpose of this study is to assess contraceptive efficacy, vaginal bleeding patterns (cycle control), general safety and acceptability of the NOMAC-E2 COC in a large group of women aged 18-50 years.
| Condition | Intervention | Phase |
|---|---|---|
|
Contraception |
Drug: Estradiol and Nomegestrol Acetate Tablets Drug: Drospirenone and Ethinyl Estradiol Tablets |
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 Contraceptive Efficacy, Cycle Control, Safety and Acceptability of a Monophasic Combined Oral Contraceptive (COC) Containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2), Compared to a Monophasic COC Containing 3 mg Drospirenone (DRSP) and 30 µg Ethinyl Estradiol (EE) |
| Enrollment: | 2152 |
| Study Start Date: | May 2006 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Estradiol and Nomegestrol Acetate Tablets
|
Drug: Estradiol and Nomegestrol Acetate Tablets
24 active plus 4 placebo tablets per cycle
|
|
2: Active Comparator
Drospirenone and Ethinyl Estradiol Tablets
|
Drug: Drospirenone and Ethinyl Estradiol Tablets
21 active plus 7 placebo tablets per cycle
|
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. 292001, P05724 |
| Study First Received: | August 2, 2007 |
| Last Updated: | October 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00511199 History of Changes |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
|
Estrogens Antineoplastic Agents, Hormonal Antineoplastic Agents Contraceptive Agents Hormone Antagonists Estradiol valerate Contraceptives, Oral Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Ethinyl Estradiol Estradiol 17 beta-cypionate |
Reproductive Control Agents Hormones Megestrol Pharmacologic Actions Estradiol Contraceptives, Oral, Combined Aldosterone Antagonists Therapeutic Uses Estradiol 3-benzoate Drospirenone Contraceptives, Oral, Synthetic Polyestradiol phosphate |