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

Phase 3

Completed

• Conditions: Contraception
• Interventions: Drug: ENG 120 µg + EE 15 µg intravaginal ring; Drug: DRSP 3 mg + EE 30 µg

• Registration Number: NCT01277211
• Lead Sponsor: Organon and Co

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 Timeline

• Study First Submitted: 2011-01-12
• Study First Submitted QC: 2011-01-12
• Study First Posted: 2011-01-14
• Study Start: 2011-09-19
• Primary Completion: 2013-09-18
• Study Completion: 2013-09-18
• Results First Submitted: 2014-09-08
• Results First Submitted QC: 2014-09-08
• Results First Posted: 2014-09-15
• Status Verified: 2022-02
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 983

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ENG-EE (NuvaRing)	ENG 120 µg + EE 15 µg intravaginal ring	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.
DRSP-EE	DRSP 3 mg + EE 30 µg	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.

Primary Outcome Measures

Name	Time	Method
Pearl Index, by Treatment Group	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).

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Intermenstrual (Breakthrough) Bleeding/Spotting, by Cycle	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	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.