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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01277211
First received: January 12, 2011
Last updated: October 4, 2013
Last verified: October 2013

January 12, 2011
October 4, 2013
September 2011
September 2013   (final data collection date for primary outcome measure)
The number of in-treatment pregnancies per 100 woman-years of exposure (Pearl Index) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01277211 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Effectiveness of NuvaRing® to Prevent Pregnancies in Chinese Women (P06450 AM5)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Contraception
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
983
September 2013
September 2013   (final data collection date for primary outcome measure)

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.
Female
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01277211
P06450
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP