| August 2, 2007 |
| October 2, 2009 |
| May 2006 |
| April 2008 (final data collection date for primary outcome measure) |
- Contraceptive efficacy as determined by serum HCG pregnancy test (or home pregnancy test) [ Time Frame: One year (13 cycles) ] [ Designated as safety issue: No ]
- Drug safety as determined by [S]AE monitoring, cervical cytology, physical & gynecological exams, vital signs, and routine laboratory parameters. [ Time Frame: One year (13 cycles) ] [ Designated as safety issue: Yes ]
- Cycle control as determined by patient [electronic] diaries. [ Time Frame: One year (13 cycles) ] [ Designated as safety issue: No ]
- Acceptability will be evaluated on the basis of discontinuation rates and reasons for discontinuation. [ Time Frame: One year (13 cycles) ] [ Designated as safety issue: No ]
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- Contraceptive efficacy as determined by serum HCG pregnancy test (or home pregnancy test). [ Time Frame: One year (13 cycles) ]
- Drug safety as determined by [S]AE monitoring, cervical cytology, physical & gynecological exams, vital signs, and routine laboratory parameters. [ Time Frame: One year (13 cycles) ]
- Cycle control as determined by patient [electronic] diaries. [ Time Frame: One year (13 cycles) ]
- Acceptability will be evaluated on the basis of discontinuation rates and reasons for discontinuation. [ Time Frame: One year (13 cycles) ]
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| Complete list of historical versions of study NCT00511199 on ClinicalTrials.gov Archive Site |
- User satisfaction will be evaluated using "Patient Reported Outcome Questionnaires" (self-administered). [ Time Frame: One year (13 cycles) ] [ Designated as safety issue: No ]
- Acne will be assessed by regular skin examinations. [ Time Frame: One year (13 cycles) ] [ Designated as safety issue: No ]
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- User satisfaction will be evaluated using "Patient Reported Outcome Questionnaires" (self-administered). [ Time Frame: One year (13 cycles) ]
- Acne will be assessed by regular skin examinations. [ Time Frame: One year (13 cycles) ]
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| Efficacy and Safety of the Combined Oral Contraceptive (COC) NOMAC-E2 Compared to a COC Containing DRSP/EE (292001)(COMPLETED)(P05724) |
| 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) |
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. |
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| Phase III |
| Interventional |
| Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Contraception |
- Drug: Estradiol and Nomegestrol Acetate Tablets
- Drug: Drospirenone and Ethinyl Estradiol Tablets
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- Active Comparator: Estradiol and Nomegestrol Acetate Tablets
- Active Comparator: Drospirenone and Ethinyl Estradiol Tablets
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| Completed |
| 2152 |
| April 2008 |
| April 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Sexually active women, at risk for pregnancy and not planning to use condoms;
- Women in need for contraception and willing to use an OC for 12 months (13 cycles);
- At least 18 but not older than 50 years of age at the time of screening;
- Body mass index = 17 and = 35;
- Good physical and mental health;
- Willing to give informed consent in writing
Exclusion Criteria:
- Contraindications for contraceptive steroids
- In accordance with the SmPC/Package Insert of DRSP-EE, additional contraindications related to the antimineralocorticoid activity of drospirenone (conditions that predispose to hyperkalemia):
- Renal insufficiency;
- Hepatic dysfunction;
- Adrenal insufficiency.
- An abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia [CIN], SIL, carcinoma in situ, invasive carcinoma) at screening;
- Clinically relevant abnormal laboratory result at screening as judged by the investigator;
- Use of an injectable hormonal method of contraception; within 6 months of an injection with a 3-month duration, within 4 months of an injection with a 2-month duration, within 2 months of an injection with a 1-month duration;
- Before spontaneous menstruation has occurred following a delivery or abortion;
- Breastfeeding or within 2 months after stopping breastfeeding prior to the start of trial medication;
- Present use or use within 2 months prior to the start of the trial medication of the following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, sex steroids (other than pre- and posttreatment contraceptive method) and herbal remedies containing Hypericum perforatum (St John's Wort);
- Administration of investigational drugs and/or participation in another clinical trial within 2 months prior to the start of the trial medication or during the trial period
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| Female |
| 18 Years to 50 Years |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
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| NCT00511199 |
| Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| Protocol No. 292001, P05724 |
| Schering-Plough |
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| Schering-Plough |
| October 2009 |