Study of the Contraceptive Efficacy and Safety of a NOMAC-E2 Combined Oral Contraceptive (COC)(P06448)

NCT01656434 | Terminated Phase 3 Results

• 3 other identifiers: P06448MK-8175A-022SCH 900121 P06448
• Study Type: interventional
• Target: 3,173
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to assess the contraceptive efficacy of a nomegestrol acetate + 17ß-estradiol (NOMAC-E2) combined oral contraceptive (COC) in healthy, sexually-active American women at risk for pregnancy. Vaginal bleeding patterns of women taking NOMAC-E2 were assessed and compared to those of women taking a norethisterone acetate + ethinyl estradiol (NETA-EE) COC. The safety of NOMAC-E2 was also assessed. Participants were randomized to receive either NOMAC-E2 or NETA-EE in a 3:1 ratio. As of Amendment 1 (which increased the sample size of the NOMAC-E2 group), the randomization ratio was adapted accordingly for participants randomized after the sample size increase.

Conditions

Contraception

Keywords

Combined Oral Contraceptives

Outcome Measures

Primary Outcomes (1)

• Number of In-Treatment Pregnancies Per 100 Woman Years of Exposure (Pearl Index)

  Primary Efficacy Outcome measure for this study was contraceptive efficacy, or the prevention of in-treatment pregnancy. The total incidence of in-treatment pregnancies was expressed as the Pearl Index, which is defined as the number of in-treatment pregnancies per 100 woman-years of exposure.

  Up to 1 year (13 cycles)

Secondary Outcomes (5)

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

  Up to 1 year (13 cycles)

• Percentage of Participants With an Absence of Withdrawal Bleeding

  Up to 1 year (13 cycles)

• Percentage of Participants Who Experienced At Least One Adverse Event

  Up to 54 weeks

• Number of Participants Who Experience at Least One Venous or Arterial Thrombotic/Thromboembolic Event

  Up to 54 weeks

• Change From Baseline in Body Weight

  Baseline and Week 52

Study Arms (2)

NOMAC-E2

EXPERIMENTAL

Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.

Drug: NOMAC-E2; Other: Placebo

NETA-EE

ACTIVE COMPARATOR

Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.

Drug: NETA-EE; Drug: ethinylestradiol (EE); Drug: ferrous fumarate

Interventions

NOMAC-E2 DRUG

NOMAC-E2 film-coated oral tablets containing 2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol.

Also known as: MK-8175A, SCH 900121, Org 10486-0 (NOMAC), Org 2317 (E2)

NOMAC-E2

NETA-EE DRUG

NETA-EE film-coated oral tablets containing 1 mg norethisterone acetate and 10 μg ethinylestradiol.

Also known as: Lo Loestrin® Fe

NETA-EE

Placebo OTHER

tablet

NOMAC-E2

ethinylestradiol (EE) DRUG

EE 10 μg tablet

NETA-EE

ferrous fumarate DRUG

ferrous fumarate 75 mg tablet

NETA-EE

Eligibility Criteria

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

You may qualify if:

• Sexually active woman, at risk for pregnancy and in need of contraception
• Not planning to use other contraceptive methods (including barrier methods \[e.g., condoms\]) than the study drug, during the study
• Willing to use a COC for 12 months (13 cycles)
• Body mass index (BMI) of ≥18 and \<38 kg/m\^2
• Good physical and mental health
• Willing to complete an electronic diary on a daily basis for the duration of the study

You may not qualify if:

• Current smoker and age of \>35 years
• Presence or history of either venous thromboembolic diseases (deep vein thrombosis \[DVT\], pulmonary embolism) or arterial thromboembolic diseases (myocardial infarction, stroke)
• History of migraine with focal neurological symptoms
• Diabetes mellitus with vascular involvement
• Less than two weeks of full remobilization from prolonged immobilization, major surgery, any surgery to the legs, or major trauma
• Severe hypertension
• Severe abnormal lipoproteins in the blood
• Pancreatic dysfunction
• Presence of history of severe liver disease or liver tumors
• Known or suspected sex steroid-influenced malignancies (e.g., of the genital organs or the breasts)
• Undiagnosed vaginal bleeding
• Known or suspected pregnancy
• Current or history of abuse of alcohol or drugs (e.g., laxatives)
• Abnormal cervical smear at screening
• Prior to start of treatment, spontaneous menstruation has not occurred following a delivery or abortion

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Rolla E. Endometriosis: advances and controversies in classification, pathogenesis, diagnosis, and treatment. F1000Res. 2019 Apr 23;8:F1000 Faculty Rev-529. doi: 10.12688/f1000research.14817.1. eCollection 2019.

  PMID: 31069056 DERIVED

MeSH Terms

Interventions

Ethinyl Estradiol; ferrous fumarate

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

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

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

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: July 31, 2012
• First Posted: August 3, 2012
• Study Start: November 2, 2012
• Primary Completion: February 12, 2014
• Study Completion: February 12, 2014
• Last Updated: June 20, 2024
• Results First Posted: March 17, 2015

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share