Phase 3
N=983
A Study to Evaluate the Effectiveness of NuvaRing® to Prevent Pregnancies in Chinese Women (P06450)
Contraception
Bottom Line
View on ClinicalTrials.gov: NCT01277211 ↗Enrolled (actual)
983
Serious AEs
0.6%
Results posted
Sep 2014
Primary outcome: Primary: Pearl Index, by Treatment Group — 1.92; 3.12 Pregnancies per 100 woman-years — p=0.531
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ENG 120 µg + EE 15 µg intravaginal ring (Drug); DRSP 3 mg + EE 30 µg (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Organon and Co
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pearl Index, by Treatment Group |
1.92; 3.12 | 0.531 |
| SECONDARY Percentage of Participants With Intermenstrual (Breakthrough) Bleeding/Spotting, by Cycle |
18.6; 21.6; 12.3; 18.5; 8.5; 14.3 | 0.346 |
| SECONDARY Percentage of Participants With Absence of Withdrawal Bleeding, by Cycle |
8.6; 14.6; 4.8; 9.7; 5.2; 11.7 | 0.015 sig |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01277211). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.