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

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: September 30, 2014
Last verified: September 2014

January 12, 2011
September 30, 2014
September 2011
September 2013   (final data collection date for primary outcome measure)
Pearl Index, by Treatment Group [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
Primary Efficacy Outcome measure for this study was contraceptive efficacy, or the prevention of in-treatment pregnancy. The total incidence of in-treatment pregnancies was expressed as the Pearl Index, which is defined as the number of in-treatment pregnancies per 100 woman-years of exposure (one woman-year defined as a period of 365.25 days).
The number of in-treatment pregnancies per 100 woman-years of exposure (Pearl Index) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01277211 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With Intermenstrual (Breakthrough) Bleeding/Spotting, by Cycle [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Participants kept diaries to record vaginal bleeding events. They were asked to record, on a daily basis, whether they experienced vaginal bleeding, which included BLEEDING or SPOTTING, at any time during a cycle other than normal menstruation while in the study. (This is also known as "breakthough" bleeding.) Vaginal bleeding that required >=2 pads/tampons per day was classified as BLEEDING. Vaginal bleeding that required <=1 pad/tampon per day was classified as SPOTTING.
  • Percentage of Participants With Absence of Withdrawal Bleeding, by Cycle [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Participants kept diaries to record vaginal bleeding events. They were asked to record, on a daily basis, whether vaginal bleeding was present. Absence of withdrawal bleeding was defined as no bleeding/spotting during the expected bleeding period.
  • 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 ]
Not Provided
Not Provided
 
A Study to Evaluate the Effectiveness of NuvaRing® to Prevent Pregnancies in Chinese Women (P06450)
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.

The purpose of this study is to assess the contraceptive efficacy of NuvaRing in fertile Chinese women; to assess vaginal bleeding pattern (cycle control), general safety, and acceptability of NuvaRing; and to evaluate the NuvaRing's effect on dysmenorrhea.

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
    13 cycles of ENG-EE (NuvaRing) vaginal ring use. Each cycle 28 days, with a 21-day active treatment period followed by 7-day ring-free period. One ring per cycle, each ring containing 11.7 mg ENG and 2.7 mg EE, and releasing on average 120 mcg/day of ENG and 15 mcg/day of EE.
    Other Name: NuvaRing
  • Drug: DRSP 3 mg + EE 30 µg
    13 cycles of DRSP-EE tablet use. Each cycle 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received total of 21 tablets per cycle, each tablet contained 3 mg DRSP and 30 μg EE.
    Other Name: Yasmin
  • Experimental: ENG-EE (NuvaRing)
    Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
    Intervention: Drug: ENG 120 µg + EE 15 µg intravaginal ring
  • Active Comparator: DRSP-EE
    Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
    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
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
September 2014

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