A Study to Evaluate the Effectiveness of NuvaRing� to Prevent Pregnancies in Chinese Women (P06450 AM4)
Information source: Schering-Plough
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contraception
Intervention: ENG 120 µg/EE 15 µg intravaginal ring (Drug); DRSP 3 mg/EE 30 µg (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Schering-Plough Overall contact:
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: The number of in-treatment pregnancies per 100 woman-years of exposure (Pearl Index)
Secondary outcome: Occurrence of breakthrough bleeding/spottingAbsence of withdrawal bleeding
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Female.
Criteria:
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.
Locations and Contacts
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734
Investigational Site 37, Chongqing 400038, China; Recruiting
Investigational Site 9, Guangzhou 510120, China; Recruiting
Investigational Site 44, Guangzhou 510120, China; Recruiting
Additional Information
Starting date: September 2011
Last updated: November 30, 2011
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