Efficacy and Safety of Oral NOMAC-E2 in Indian Women (P07057/MK-8175A-017)

Contraception Clinical Trial

Official title:

An Open-label, Multi-center Trial to Evaluate the Contraceptive Efficacy, Safety and Acceptability of a Monophasic Combined Oral Contraceptive (COC) Containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) in Indian Women. Protocol MK-8175A-017-00

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01723579
• Other study ID #: P07057
• Secondary ID: MK-8175A-017
• Status: Withdrawn
• Phase: Phase 3
• Start date: July 2013
• Est. completion date: May 2015

Study information

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

Clinical Trial Summary

This study will investigate the efficacy and safety of the monophasic

combined oral contraceptive (COC) containing 2.5 mg NOMAC and 1.5 mg E2 in

healthy fertile Indian women.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Sexually active and at risk for pregnancy

• Of Indian descent, born in India, never emigrated out of India, with Indian

home address

• Body mass index (BMI) =17 and =35 kg/m^2

Exclusion Criteria:

• Presence or history of venous or arterial thrombotic/thromboembolic events

or cerebrovascular accident

• Presence or history of prodromi of a thrombosis

• History of migraine with focal neurological symptoms

• Diabetes mellitus with vascular involvement

• Presence of a severe or multiple risk factor(s) for venous or arterial

thrombosis

• Severe hypertension

• Severe dyslipoproteinemia

• Presence or history of pancreatitis associated with severe

hypertriglyceridemia

• Presence or history of severe hepatic disease

• Undiagnosed vaginal bleeding

• Known or suspected pregnancy

• Currently breastfeeding or breastfeeding within 2 months of starting

trial medication

• Investigational drug use or participation in another clinical trial within

2 months of signing Informed Consent Form for current trial

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Nomegestrol acetate (NOMAC)
Oral tablet with daily release of 2.5 mg
• Estradiol (E2)
Daily release of 1.5 mg

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		Day 1 of Treatment Cycle 1 Through Day 28 of Treatment Cycle 13, plus up to 2 additional days (Study Days 1-366)
Secondary	Number of Participants Experiencing an Adverse Event (AE) or Serious AE		"From Visit 1 up to 30 days after the last dose of study medication (up to Study Day 394).