Official Title: “A Randomized, Open-Label, Comparative, Multi -Center Trial to Evaluate Contraceptive Efficacy, Cycle Control, Safety and Acceptability 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 µg Ethinyl Estradiol (EE)”

The primary purpose of this study is to assess contraceptive efficacy, vaginal bleeding patterns (cycle control), general safety and acceptability of the NOMAC-E2 COC in a large group of women aged 18-50 years.

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2008

Intervention(s) in this Clinical Trial

• Drug: NOMAC E2
  • NOMAC-E2 COC (24 active plus 4 placebo tablets per cycle)
• Drug: drospirenone and ethinyl estradiol tablets
  • 21 active plus 7 placebo tablets per cycle)

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • nomegestrol acetate (NOMAC) and estradiol (E2)
• Active Comparator: 2
  • drospirenone and ethinyl estradiol tablets

Primary Measures

• Contraceptive efficacy as determined by serum HCG pregnancy test (or home pregnancy test).
  • Time Frame: One year (13 cycles)
    Safety Issue?: No
• Drug safety as determined by [S]AE monitoring, cervical cytology, physical & gynecological exams, vital signs, and routine laboratory parameters.
  • Time Frame: One year (13 cycles)
    Safety Issue?: Yes
• Cycle control as determined by patient [electronic] diaries.
  • Time Frame: One year (13 cycles)
    Safety Issue?: No
• Acceptability will be evaluated on the basis of discontinuation rates and reasons for discontinuation.
  • Time Frame: One year (13 cycles)
    Safety Issue?: No

Secondary Measures

• User satisfaction will be evaluated using "Patient Reported Outcome Questionnaires" (self-administered).
  • Time Frame: One year (13 cycles)
    Safety Issue?: No
• Acne will be assessed by regular skin examinations.
  • Time Frame: One year (13 cycles)
    Safety Issue?: No

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 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 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], 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).

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

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

Lead Sponsor: Organon

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00413062

Study ID Number: Organon protocol 292002

ClinicalTrials.gov Identifier: NCT00413062

Health Authority: United States: Food and Drug Administration