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Trial record 22 of 27 for:    DROSPIRENONE AND ETHINYL ESTRADIOL AND bleeding

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

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ClinicalTrials.gov Identifier: NCT01277211
Recruitment Status : Completed
First Posted : January 14, 2011
Results First Posted : September 15, 2014
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE January 12, 2011
First Posted Date  ICMJE January 14, 2011
Results First Submitted Date  ICMJE September 8, 2014
Results First Posted Date  ICMJE September 15, 2014
Last Update Posted Date August 31, 2018
Actual Study Start Date  ICMJE September 19, 2011
Actual Primary Completion Date September 18, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2014)
Pearl Index, by Treatment Group [ Time Frame: Up to 1 year ]
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).
Original 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 ]
Change History Complete list of historical versions of study NCT01277211 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2014)
  • Percentage of Participants With Intermenstrual (Breakthrough) Bleeding/Spotting, by Cycle [ Time Frame: Up to 1 year ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2011)
  • Occurrence of breakthrough bleeding/spotting [ Time Frame: 12 months ]
  • Absence of withdrawal bleeding [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Effectiveness of NuvaRing® to Prevent Pregnancies in Chinese Women (P06450)
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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Contraception
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Fan GS, Ren M, Di W, Su P, Chang Q, Wu S, Qin Y, Korver T, Marintcheva-Petrova M, Yacik C, McCrary Sisk C, Wang G. Efficacy and safety of the contraceptive vaginal ring (NuvaRing) compared with a combined oral contraceptive in Chinese women: a 1-year randomised trial. Eur J Contracept Reprod Health Care. 2016 Aug;21(4):303-9. doi: 10.1080/13625187.2016.1186269. Epub 2016 Jun 24.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: October 4, 2013)
983
Original Estimated Enrollment  ICMJE
 (submitted: January 12, 2011)
720
Actual Study Completion Date  ICMJE September 18, 2013
Actual Primary Completion Date September 18, 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries China
 
Administrative Information
NCT Number  ICMJE NCT01277211
Other Study ID Numbers  ICMJE P06450
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date August 2018

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