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)”

The primary purpose of this study is to evaluate the effects of the NOMAC-E2 combined oral contraceptive on ovarian function.

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacodynamics Study

Study Primary Completion Date: January 2008

Intervention(s) in this Clinical Trial

• Drug: Estradiol and Nomegestrol Acetate Tablets
  • (1.5 mg / 2.5 mg), 6 cycles, tablets
• Drug: Drospirenone and Ethinyl Estradiol Tablets
  • (3 mg / 30 ug), tablets

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Estradiol and Nomegestrol Acetate Tablets (1.5 mg / 2.5 mg)
• Active Comparator: 2
  • Drospirenone and Ethinyl Estradiol Tablets (3 mg / 30 ug)

Primary Measures

• Ovarian function as determined by blood sampling (P, FSH, LH and E2), and vaginal USS of the ovaries to assess follicular growth
  • Time Frame: 6 months
    Safety Issue?: No

Secondary Measures

• Return of ovulation as determined by blood sampling (P levels) and vaginal USS of the ovaries to assess follicular growth
  • Time Frame: 6 months
    Safety Issue?: No
• Effects on cervical mucus as determined by Insler score
  • Time Frame: 6 months
    Safety Issue?: No
• Effects on endometrial thickness as determined by vaginal USS of the endometrium
  • Time Frame: 6 months
    Safety Issue?: No
• Effects on androgen, SHBG and folic acid levels as determined by blood sampling.
  • Time Frame: 6 months
    Safety Issue?: No
• Contraceptive efficacy as determined by serum HCG pregnancy test (or home pregnancy test).
  • Time Frame: 6 months
    Safety Issue?: No
• Drug safety as determined by [S]AE monitoring, cervical cytology, physical & gynecological exams, and monitoring vital signs.
  • Time Frame: 6 months
    Safety Issue?: Yes
• Cycle control as determined by patient diary records.
  • Time Frame: 6 months
    Safety Issue?: No

Inclusion Criteria:

• Willing to use COC for at least 6 cycles.
• 18 - 35 years of age at screening.
• 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 Wort0.
• 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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 35 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Organon

Information obtained from ClinicalTrials.gov on August 27, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00511433

Study ID Number: 292003

ClinicalTrials.gov Identifier: NCT00511433

Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)