Efficacy and Safety of the Combined Oral Contraceptive (COC) NOMAC-E2 Compared to a COC Containing DRSP/EE (292001)(COMPLETED)(P05724)

NCT ID: NCT00511199

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-01
• Study Completion Date: 2008-04-01

Brief Summary

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

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 13 consecutive 28-day menstrual cycles (1 year).

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 13 consecutive 28-day menstrual cycles (1 year).

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 13 consecutive 28-day menstrual cycles (1 year).

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 13 consecutive 28-day menstrual cycles (1 year).

Intervention Type: DRUG

Other Intervention Names

SCH 900121; SCH 900121

Eligibility Criteria

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 oral contraceptive (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 (BMI) of >/= 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 Summary of Product Characteristics (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],

Squamous Intraepithelial Lesion [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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Mansour D, Verhoeven C, Sommer W, Weisberg E, Taneepanichskul S, Melis GB, Sundstrom-Poromaa I, Korver T. Efficacy and tolerability of a monophasic combined oral contraceptive containing nomegestrol acetate and 17beta-oestradiol in a 24/4 regimen, in comparison to an oral contraceptive containing ethinylestradiol and drospirenone in a 21/7 regimen. Eur J Contracept Reprod Health Care. 2011 Dec;16(6):430-43. doi: 10.3109/13625187.2011.614029. Epub 2011 Oct 13.

Reference Type: RESULT

PMID: 21995590 (View on PubMed)

Witjes H, Creinin MD, Sundstrom-Poromaa I, Martin Nguyen A, Korver T. Comparative analysis of the effects of nomegestrol acetate/17 beta-estradiol and drospirenone/ethinylestradiol on premenstrual and menstrual symptoms and dysmenorrhea. Eur J Contracept Reprod Health Care. 2015;20(4):296-307. doi: 10.3109/13625187.2015.1016154. Epub 2015 Feb 25.

Reference Type: DERIVED

PMID: 25712537 (View on PubMed)

Other Identifiers

Organon Protocol No. 292001

Identifier Type: -

Identifier Source: secondary_id

P05724

Identifier Type: -

Identifier Source: org_study_id