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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01656434
First received: July 31, 2012
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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
Contraception
Drug: NOMAC-E2
Drug: NETA-EE
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)
Drug: NETA-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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01656434     History of Changes
Other Study ID Numbers: P06448, MK-8175A-022, SCH 900121 P06448
Study First Received: July 31, 2012
Last Updated: April 28, 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
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on September 30, 2014