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

Contraception Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01277211
• Other study ID #: P06450
• Status: Completed
• Phase: Phase 3
• Start date: September 19, 2011
• Est. completion date: September 18, 2013

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 983
• Est. completion date: September 18, 2013
• Est. primary completion date: September 18, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Contraception

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

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 rand — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pearl Index, by Treatment Group	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).	Up to 1 year
Secondary	Percentage of Participants With Intermenstrual (Breakthrough) Bleeding/Spotting, by Cycle	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.	Up to 1 year
Secondary	Percentage of Participants With Absence of Withdrawal Bleeding, by Cycle	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.	Up to 1 year