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

This study has been terminated.
(Business reasons)
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: July 31, 2012
Last updated: December 3, 2014
Last verified: December 2014

The purpose of this study is 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 will be assessed and compared to those of women taking a norethisterone acetate + ethinyl estradiol (NETA-EE) COC. The safety of NOMAC-E2 will also be assessed.

Participants will be 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 will be adapted accordingly for participants randomized after the sample size increase.

Condition Intervention Phase
Drug: NOMAC-E2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase III, Randomized, Open-label, Active-controlled, Multicenter Trial to Study the Contraceptive Efficacy and Safety of the Commercial Batch of Oral Tablets of MK-8175A (Nomegestrol Acetate - 17ß-estradiol) in Healthy, Sexually-active Women Aged 18-50 Years

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of In-Treatment Pregnancies Per 100 Woman Years of Exposure (Pearl Index) [ Time Frame: 1 year (13 cycles) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Participants with an Occurrence of Breakthrough Bleeding/Spotting [ Time Frame: Every 28-day cycle for 13 cycles (one year total) ] [ Designated as safety issue: No ]
  • Percentage of Participants with an Absence of Withdrawal Bleeding [ Time Frame: Every 28-day cycle for 13 cycles (one year total) ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Experience At Least One Adverse Event [ Time Frame: Up to 54 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Who Experience at Least One Venous or Arterial Thrombotic/Thromboembolic Event [ Time Frame: Up to 54 weeks ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Body Weight [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: Yes ]

Enrollment: 3173
Study Start Date: November 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NOMAC-E2
Nomegestrol Acetate (NOMAC) and Estradiol (E2)
Drug: NOMAC-E2

Film-coated oral tablets, taken once daily for 13 cycles of 28 days each.

Each cycle consists of the following tablets:

  • NOMAC/E2 2.5 mg/1.5 mg tablets (white), taken on Days 1-24 and
  • Placebo tablets (yellow), taken on Days 25-28
Other Names:
  • MK-8175A
  • SCH 900121
  • Org 10486-0 (NOMAC)
  • Org 2317 (E2)
Active Comparator: NETA-EE
Norethisterone Acetate (NETA) and Ethinyl Estradiol (EE)

Film-coated oral tablets, taken once daily for 13 cycles of 28 days each.

Each cycle consists of the following tablets:

  • NETA/EE 1 mg/10 mcg tablets (blue), taken on Days 1-24,
  • EE 10 mcg tablets (white), taken on Days 25-26, and
  • ferrous fumarate 75 mg tablets (brown), taken on Days 27-28
Other Name: Lo Loestrin® Fe


Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Breastfeeding or has been breastfeeding within 2 months prior to start of treatment
  • Use of any investigational drugs and/or participation in any other clinical trial within 2 months prior to start of treatment
  • Use of any of the following medications prior to or during the study may prohibit inclusion: sex hormones (other than pre- and post-treatment non-injectable contraceptives), injectable hormonal contraception, phenytoin, barbiturates, primidone, bosentan, carbamazepine, topiramate, felbamate, rifampicin, ritonavir, nevirapine, efavirenz, griseofulvin, herbal remedies containing Hypericum perforatum (e.g., St. John's wort)
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01656434     History of Changes
Other Study ID Numbers: P06448, MK-8175A-022, SCH 900121 P06448
Study First Received: July 31, 2012
Last Updated: December 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Combined Oral Contraceptives

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral, Combined
Contraceptive Agents, Female
Contraceptives, Oral
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses processed this record on March 03, 2015