A Study to Evaluate the Effectiveness of NuvaRing® to Prevent Pregnancies in Chinese Women (P06450 AM5)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT01277211

First received: January 12, 2011

Last updated: May 14, 2013

Last verified: May 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	January 12, 2011
Last Updated Date	May 14, 2013
Start Date ^ICMJE	September 2011
Estimated Primary Completion Date	September 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 12, 2011)	The number of in-treatment pregnancies per 100 woman-years of exposure (Pearl Index) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01277211 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 12, 2011)	Occurrence of breakthrough bleeding/spotting [ Time Frame: 12 months ] [ Designated as safety issue: No ] Absence of withdrawal bleeding [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study to Evaluate the Effectiveness of NuvaRing® to Prevent Pregnancies in Chinese Women (P06450 AM5)
Official Title ^ICMJE	A Randomized, Open-Label, Controlled, Multi-Center Trial to Evaluate the Contraceptive Efficacy, Cycle Control, Safety and Acceptability of NuvaRing® (SCH 900702) in Chinese Women
Brief Summary	This is a study to assess the effectiveness of NuvaRing® (SCH 900702) for the prevention of pregnancy in fertile Chinese women. The acceptability and safety of NuvaRing® will also be assessed and compared with that of Yasmin.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Contraception
Intervention ^ICMJE	Drug: ENG 120 µg/EE 15 µg intravaginal ring Etonogestrel (ENG) 120 µg/Ethinylestradiol (EE) 15 µg over a period of 3 weeks. One cycle consists of 21-days of NuvaRing use followed by a ring-free week. NuvaRing will be used for 13 cycles of 28 days. Other Name: NuvaRing Drug: DRSP 3 mg/EE 30 µg DRSP 3 mg/EE 30 µg will be taken for 13 cycles of 28 days, each cycle consisting of: One tablet daily for 21 consecutive days followed by 7 tablet-free days Other Name: Yasmin
Study Arm (s)	Experimental: Etonogestrel (ENG) 120 µg/Ethinylestradiol (EE) 15 µg Intervention: Drug: ENG 120 µg/EE 15 µg intravaginal ring Active Comparator: Drospirenone (DRSP) 3 mg-Ethinylestradiol (EE) 30 µg Intervention: Drug: DRSP 3 mg/EE 30 µg
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	960
Estimated Completion Date	September 2013
Estimated Primary Completion Date	September 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Key Inclusion Criteria: Sexually active Chinese women, at risk for pregnancy and not planning to use condoms during trial medication use Women in need for contraception and willing to use a hormonal contraceptive method for 13 cycles Body mass index ≥18 and ≤29 kg/m^2 Key Exclusion Criteria: Contraindications for contraceptive steroids Abnormal cervical smear corresponding to indeterminate changes at screening Clinically relevant abnormal laboratory result at screening as judged by the investigator.
Gender	Female
Ages	18 Years to 40 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01277211
Other Study ID Numbers ^ICMJE	P06450
Has Data Monitoring Committee	No
Responsible Party	Merck
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	May 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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