Phase 3 N=48 Randomized Prevention

Effects on Ovarian Function of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292003)(COMPLETED)(P05723)

Contraception

Bottom Line

View on ClinicalTrials.gov: NCT00511433 ↗

Enrolled (actual)

Serious AEs

2.1%

Results posted

Aug 2011

Primary outcome: Primary: Effect on Ovarian Function as Determined by the Number of Participants With an Occurrence of Ovulation — 0; 0; 0; 0 Participants

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: Jan 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Effect on Ovarian Function as Determined by the Number of Participants With an Occurrence of Ovulation	0; 0; 0; 0; 0; 0	—
PRIMARY Effect on Ovarian Function as Determined by the Maximum Follicle Diameter	19.3; 19.6; 7.6; 8.1; 8.2; 10.8	—
PRIMARY Effect on Ovarian Function as Determined by the Maximum Progesterone Value	38.7; 38.7; 1.7; 1.6; 1.5; 1.5	—
PRIMARY Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2)	168.75; 79.82; 194.57; 66.66; 172.35; 61.15	—
PRIMARY Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH)	4.29; 4.51; 4.08; 4.23; 3.59; 3.40	—
PRIMARY Effect on Ovarian Function as Determined by Luteinizing Hormone (LH)	3.73; 3.69; 2.98; 4.34; 2.50; 3.09	—
SECONDARY Effect on Cervical Mucus as Determined by Insler Score	8.9; 7.3; 2.3; 3.2; NA; 4.5	—
SECONDARY Effect on Maximum Endometrial Thickness	9.9; 10.1; 5.9; 6.1; 5.3; 6.8	—
SECONDARY Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)	0; 0	—
SECONDARY Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting	7; 1; 6; 0; 5; 0	—
SECONDARY Number of Participants With an Occurrence of Absence of Withdrawal Bleeding	3; 0; 2; 0; 2; 0	—
SECONDARY Number of Participants With an Occurrence of Breakthrough Bleeding	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)	7; 1; 6; 0; 5; 0	—
SECONDARY Number of Participants With an Occurrence of Early Withdrawal Bleeding	4; 2; 4; 0; 1; 0	—
SECONDARY Number of Participants With an Occurrence of Continued Withdrawal Bleeding	11; 12; 8; 10; 8; 11	—
SECONDARY Average Number of Breakthrough Bleeding/Spotting Days	3.0; 2.0; 2.7; NA; 2.2; NA	—
SECONDARY Average Number of Withdrawal Bleeding Days	7.2; 7.0; 7.4; 5.0; 4.3; 5.4	—

Summary

The primary purpose of this study is to evaluate the effects of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) on ovarian function.

Eligibility Criteria

Inclusion Criteria

Willing to use COC for at least 6 cycles.
18 - 35 years of age at screening.
Body Mass Index (BMI) of >/= 17 and </= 35.
Good physical and mental health.
Willing to use condoms as the sole contraceptive method during screening cycle and 1 post-treatment cycle.
Willing to give informed consent.

Exclusion Criteria

Contraindications for contraceptive steroids (general).
Additional contraindications (renal, hepatic or adrenal insufficiency).
Breastfeeding.
Present use (or use within 2 months prior to 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 post treatment contraceptive method) and herbal remedies containing Hypericum perforatum (St. John's Wort).

Administration of any other 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.
Abnormal cervical smear at screening, or documentation of an abnormal smear performed within 6 months before screening.
Clinically relevant abnormal laboratory result at screening as judged by the investigator.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00511433). 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.