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

NCT00511433 | Completed Phase 3 Results

• 2 other identifiers: P05723Organon protocol 292003
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Contraception

Outcome Measures

Primary Outcomes (6)

• Effect on Ovarian Function as Determined by the Number of Participants With an Occurrence of Ovulation

  During treatment, ovulation was assessed for each participant by the investigator on the basis of ultrasound scanning (USS). The final analysis was based on assessor-blind adjudication.

  Cycle 1, Cycle 2, and Cycle 6

• Effect on Ovarian Function as Determined by the Maximum Follicle Diameter

  The maximum follicular diameter was defined as the largest follicular diameter during a treatment cycle.

  Screening cycle, Cycle 1, Cycle 2, Cycle 3, and Cycle 6

• Effect on Ovarian Function as Determined by the Maximum Progesterone Value

  The maximum progesterone value was defined as the largest value during a cycle.

  Screening cycle, Cycle 1, Cycle 2, Cycle 3, and Cycle 6

• Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2)

  The parameter was measured at pre-defined study days.

  Cycle 1, Cycle 2, Cycle 3, and Cycle 6

• Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH)

  The parameter was measured at pre-defined study days.

  Cycle 1, Cycle 2, Cycle 3, and Cycle 6

• Effect on Ovarian Function as Determined by Luteinizing Hormone (LH)

  The parameter was measured at pre-defined study days.

  Cycle 1, Cycle 2, Cycle 3, and Cycle 6

Secondary Outcomes (11)

• Effect on Cervical Mucus as Determined by Insler Score

  Screening Cycle, Cycle 1, Cycle 2, and Cycle 7 (post-treatment cycle)

• Effect on Maximum Endometrial Thickness

  Screening Cycle, Cycle 1, Cycle 2, and Cycle 6

• Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)

  6 cycles

• Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting

  Every 28-day cycle for 6 cycles

• Number of Participants With an Occurrence of Absence of Withdrawal Bleeding

  Every 28-day cycle for 6 cycles

Study Arms (2)

NOMAC-E2

EXPERIMENTAL

Nomegestrol Acetate (NOMAC) and Estradiol (E2), 2.5 mg NOMAC and 1.5 mg E2 monophasic combined oral contraceptive

Drug: NOMAC-E2

DRSP-EE

ACTIVE COMPARATOR

Drospirenone (DRSP) and Ethinyl Estradiol (EE), 3 mg DRSP and 30 mcg EE monophasic combined oral contraceptive

Drug: DRSP-EE

Interventions

NOMAC-E2 DRUG

Nomegestrol Acetate and Estradiol Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day menstrual cycles.

NOMAC-E2

DRSP-EE DRUG

Drospirenone and Ethinyl Estradiol Tablets, 3 mg DRSP and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day menstrual cycles.

DRSP-EE

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Willing to use COC for at least 6 cycles.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• 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.

  PMID: 20695770 RESULT

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2007
• First Posted: August 3, 2007
• Study Start: October 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: February 9, 2022
• Results First Posted: August 29, 2011

Record last verified: 2022-02