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

Contraception Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01656434
• Other study ID #: P06448
• Secondary ID: MK-8175A-022SCH
• Status: Terminated
• Phase: Phase 3
• Start date: November 2, 2012
• Est. completion date: February 12, 2014

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study was terminated early. The decision to terminate the study was based upon difficulties encountered with data collection (related to incomplete e-Diary entries) in concert with business considerations. The decision was not related to any new or unexpected safety or efficacy findings with NOMAC-E2. As a result of this early termination, none of the pre-specified efficacy endpoints were analyzed.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3173
• Est. completion date: February 12, 2014
• Est. primary completion date: February 12, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• NOMAC-E2
NOMAC-E2 film-coated oral tablets containing 2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol.
• NETA-EE
NETA-EE film-coated oral tablets containing 1 mg norethisterone acetate and 10 µg ethinylestradiol.

Other:
• Placebo
tablet

Drug:
• ethinylestradiol (EE)
EE 10 µg tablet
• ferrous fumarate
ferrous fumarate 75 mg tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Participants With an Occurrence of Breakthrough Bleeding/Spotting	Participants kept e-diaries to record their vaginal bleeding events. They were asked to record, on a daily basis, whether they experienced vaginal bleeding, which included BLEEDING or SPOTTING, at any time during a cycle other than normal menstruation while in the study. (This is also known as "breakthough" bleeding.) Vaginal bleeding that required >=1 pad/tampon per day was classified as BLEEDING. Vaginal bleeding that did not require a pad/tampon per day was classified as SPOTTING.	Up to 1 year (13 cycles)
Secondary	Percentage of Participants With an Absence of Withdrawal Bleeding	Participants kept e-diaries to record vaginal bleeding events. They were asked to record, on a daily basis, whether vaginal bleeding was present. Absence of withdrawal bleeding was defined as no bleeding/spotting during the expected bleeding period.	Up to 1 year (13 cycles)
Secondary	Percentage of Participants Who Experienced At Least One Adverse Event	An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.	Up to 54 weeks
Secondary	Number of Participants Who Experience at Least One Venous or Arterial Thrombotic/Thromboembolic Event		Up to 54 weeks
Secondary	Change From Baseline in Body Weight	Participants' body weights were measured in a consistent manner throughout the trial, using standardized equirpment. Last In-Treatment Measurement refers to a participant's end of trial visit, the timing of which differed among participants.	Baseline and Week 52