Clinical trial NCT00511433: Effects on Ovarian Function of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292003)(COMPLETED)(P05723)
Official title: A Randomized, Open-Label, Comparative Trial to Evaluate the Effects on Ovarian Function 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 ug Ethinyl Estradiol (EE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2007-08-03
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Primary outcomes:
measure: Effect on Ovarian Function as Determined by the Number of Participants With an Occurrence of Ovulation
timeFrame: Cycle 1, Cycle 2, and Cycle 6
measure: Effect on Ovarian Function as Determined by the Maximum Follicle Diameter
timeFrame: Screening cycle, Cycle 1, Cycle 2, Cycle 3, and Cycle 6
measure: Effect on Ovarian Function as Determined by the Maximum Progesterone Value
timeFrame: Screening cycle, Cycle 1, Cycle 2, Cycle 3, and Cycle 6
measure: Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2)
timeFrame: Cycle 1, Cycle 2, Cycle 3, and Cycle 6
measure: Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH)
timeFrame: Cycle 1, Cycle 2, Cycle 3, and Cycle 6
measure: Effect on Ovarian Function as Determined by Luteinizing Hormone (LH)
timeFrame: Cycle 1, Cycle 2, Cycle 3, and Cycle 6
Secondary outcomes:
measure: Effect on Cervical Mucus as Determined by Insler Score
timeFrame: Screening Cycle, Cycle 1, Cycle 2, and Cycle 7 (post-treatment cycle)
measure: Effect on Maximum Endometrial Thickness
timeFrame: Screening Cycle, Cycle 1, Cycle 2, and Cycle 6
measure: Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)
timeFrame: 6 cycles
measure: Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting
timeFrame: Every 28-day cycle for 6 cycles
measure: Number of Participants With an Occurrence of Absence of Withdrawal Bleeding
timeFrame: Every 28-day cycle for 6 cycles
measure: Number of Participants With an Occurrence of Breakthrough Bleeding
timeFrame: Every 28-day cycle for 6 cycles
measure: Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)
timeFrame: Every 28-day cycle for 6 cycles
measure: Number of Participants With an Occurrence of Early Withdrawal Bleeding
timeFrame: Every 28-day cycle for 6 cycles
measure: Number of Participants With an Occurrence of Continued Withdrawal Bleeding
timeFrame: Every 28-day cycle for 5 cycles
measure: Average Number of Breakthrough Bleeding/Spotting Days
timeFrame: Every 28-day cycle for 6 cycles
measure: Average Number of Withdrawal Bleeding Days
timeFrame: Every 28-day cycle for 6 cycles
Other outcomes:
Locations:
Study officials:
References:
citation: Duijkers IJ, Klipping C, Grob P, Korver T. Effects of a monophasic combined oral contraceptive containing nomegestrol acetate and 17 beta-oestradiol on ovarian function in comparison to a monophasic combined oral contraceptive containing drospirenone and ethinylestradiol. Eur J Contracept Reprod Health Care. 2010 Oct;15(5):314-25. doi: 10.3109/13625187.2010.504313.