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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01723579
Other study ID # P07057
Secondary ID MK-8175A-017
Status Withdrawn
Phase Phase 3
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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).
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