Efficacy and Safety Study of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292002)(P05722)

NCT00413062 | Completed Phase 3 Results

• 2 other identifiers: P05722292002
• Study Type: interventional
• Target: 2,281
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

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

  In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a maximum of two days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant.

  1 year (13 cycles)

• Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index)

  In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a period of 14 days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant.

  1 year (13 cycles)

Secondary Outcomes (8)

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

  Every 28-day cycle for 13 cycles (one year total)

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

  Every 28-day cycle for 13 cycles (one year total)

• Number of Participants With an Occurrence of Breakthrough Bleeding

  Every 28-day cycle for 13 cycles (one year total)

• Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)

  Every 28-day cycle for 13 cycles (one year total)

• Number of Participants With an Occurrence of Early Withdrawal Bleeding

  Every 28-day cycle for 13 cycles (one year total)

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

Also known as: SCH900121, ORG10486-ORG2317

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

Also known as: Yasmin

DRSP-EE

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 \>=17 and \<=35;
• Good physical and mental health;
• Willing to give informed consent in writing.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (2)

• 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.

  PMID: 25712537 DERIVED

• Westhoff C, Kaunitz AM, Korver T, Sommer W, Bahamondes L, Darney P, Verhoeven C. Efficacy, safety, and tolerability of a monophasic oral contraceptive containing nomegestrol acetate and 17beta-estradiol: a randomized controlled trial. Obstet Gynecol. 2012 May;119(5):989-99. doi: 10.1097/AOG.0b013e318250c3a0.

  PMID: 22525910 DERIVED

MeSH Terms

Interventions

drospirenone and ethinyl estradiol combination

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: December 18, 2006
• First Posted: December 19, 2006
• Study Start: June 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: February 9, 2022
• Results First Posted: August 29, 2011

Record last verified: 2022-02