Phase 3
N=2,220
Efficacy and Safety Study of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292002)(P05722)
Contraception
Bottom Line
View on ClinicalTrials.gov: NCT00413062 ↗Enrolled (actual)
2,220
Serious AEs
1.7%
Results posted
Aug 2011
Primary outcome: Primary: Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) — 1.754; 3.005; 1.963; 3.092 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
- Aug 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) |
1.754; 3.005; 1.963; 3.092; 0.807; 2.572 | — |
| PRIMARY Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index) |
2.192; 4.293; 2.498; 4.638; 0.807; 2.572 | — |
| SECONDARY Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting |
370; 84; 243; 55; 196; 40 | — |
| SECONDARY Number of Participants With an Occurrence of Absence of Withdrawal Bleeding |
216; 23; 167; 15; 178; 15 | — |
| SECONDARY Number of Participants With an Occurrence of Breakthrough Bleeding |
100; 19; 47; 5; 43; 5 | — |
| SECONDARY Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) |
306; 72; 211; 50; 168; 36 | — |
| SECONDARY Number of Participants With an Occurrence of Early Withdrawal Bleeding |
175; 46; 68; 14; 66; 24 | — |
| SECONDARY Number of Participants With an Occurrence of Continued Withdrawal Bleeding |
367; 216; 309; 174; 225; 149 | — |
| SECONDARY Average Number of Breakthrough Bleeding/Spotting Days |
4.5; 4.0; 3.5; 2.7; 3.2; 2.6 | — |
| SECONDARY Average Number of Withdrawal Bleeding/Spotting Days |
5.7; 6.0; 5.0; 6.2; 4.8; 6.6 | — |
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 >=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.
- Subjects with a diagnosis of the endometrial biopsy such as hyperplasia, atypical hyperplasia, carcinoma or any other abnormality judged clinically relevant by the investigator (This is applicable only for the subjects participating in the endometrial biopsy substudy).
Data sourced from ClinicalTrials.gov (NCT00413062). 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.