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

NCT ID: NCT00511433

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2008-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

NOMAC-E2

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

Group Type: EXPERIMENTAL

NOMAC-E2

Intervention Type: 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.

DRSP-EE

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

Group Type: ACTIVE_COMPARATOR

DRSP-EE

Intervention Type: 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.

Interventions

NOMAC-E2

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.

Intervention Type: DRUG

DRSP-EE

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: RESULT

PMID: 20695770 (View on PubMed)

Other Identifiers

Organon protocol 292003

Identifier Type: -

Identifier Source: secondary_id

P05723

Identifier Type: -

Identifier Source: org_study_id