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Sponsored by: |
Organon |
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Information provided by: | Organon |
ClinicalTrials.gov Identifier: | NCT00413062 |
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 |
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Contraception |
Drug: NOMAC E2 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) |
Estimated Enrollment: | 2320 |
Study Start Date: | May 2006 |
Study Completion Date: | July 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
nomegestrol acetate (NOMAC) and estradiol (E2)
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Drug: NOMAC E2
NOMAC-E2 COC (24 active plus 4 placebo tablets per cycle)
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2: Active Comparator
drospirenone and ethinyl estradiol tablets
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Drug: drospirenone and ethinyl estradiol tablets
21 active plus 7 placebo tablets per cycle)
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Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | NV Organon, part of Schering-Plough Corporation ( Study Director ) |
Study ID Numbers: | Organon protocol 292002 |
Study First Received: | December 18, 2006 |
Last Updated: | August 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00413062 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Estrogens Contraceptive Agents Hormone Antagonists Estradiol valerate Contraceptives, Oral Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Ethinyl Estradiol |
Estradiol 17 beta-cypionate Hormones Estradiol Contraceptives, Oral, Combined Aldosterone Antagonists Estradiol 3-benzoate Drospirenone Polyestradiol phosphate |
Estrogens Contraceptive Agents Hormone Antagonists 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 Aldosterone Antagonists Therapeutic Uses Drospirenone |