Phase 3
N=2,126
Efficacy and Safety of the Combined Oral Contraceptive (COC) NOMAC-E2 Compared to a COC Containing DRSP/EE (292001)(COMPLETED)(P05724)
Contraception
Bottom Line
View on ClinicalTrials.gov: NCT00511199 ↗Enrolled (actual)
2,126
Serious AEs
2.4%
Results posted
Aug 2011
Primary outcome: Primary: Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) — 0.467; 1.017; 0.571; 1.261 Pregnancies per 100 woman years
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- NOMAC-E2 (Drug); DRSP-EE (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Organon and Co
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) |
0.467; 1.017; 0.571; 1.261; 0.000; 0.000 | — |
| PRIMARY Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index) |
0.817; 1.356; 0.999; 1.682; 0.000; 0.000 | — |
| SECONDARY Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting |
483; 130; 289; 75; 297; 54 | — |
| SECONDARY Number of Participants With an Occurrence of Absence of Withdrawal Bleeding |
284; 14; 237; 17; 258; 18 | — |
| SECONDARY Number of Participants With an Occurrence of Breakthrough Bleeding |
129; 24; 63; 20; 61; 16 | — |
| SECONDARY Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) |
408; 118; 244; 58; 257; 42 | — |
| SECONDARY Number of Participants With an Occurrence of Early Withdrawal Bleeding |
142; 52; 93; 29; 80; 22 | — |
| SECONDARY Number of Participants With an Occurrence of Continued Withdrawal Bleeding |
412; 283; 406; 274; 364; 243 | — |
| SECONDARY Average Number of Breakthrough Bleeding/Spotting Days |
4.6; 4.2; 3.5; 3.2; 3.4; 3.6 | — |
| SECONDARY Average Number of Withdrawal Bleeding/Spotting Days |
5.7; 6.0; 5.6; 5.5; 5.9; 5.4 | — |
Summary
The primary purpose of this study is to assess contraceptive efficacy, vaginal bleeding patterns (cycle control), general safety and acceptability of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) in a large group of women aged 18-50 years.
Eligibility Criteria
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 oral contraceptive (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 (BMI) of >/= 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 Summary of Product Characteristics (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],
Squamous Intraepithelial Lesion [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.
Data sourced from ClinicalTrials.gov (NCT00511199). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.