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.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Drug: ENG 120 µg + EE 15 µg intravaginal ring; Drug: DRSP 3 mg + EE 30 µg

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: Interventional
• Enrollment (Actual): 983
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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 Names: NuvaRing
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.	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 Names: Yasmin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Organon and Co

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2011
• Primary Completion (Actual): September 18, 2013
• Study Completion (Actual): September 18, 2013

Study Registration Dates

• First Submitted: January 12, 2011
• First Submitted That Met QC Criteria: January 12, 2011
• First Posted (Estimate): January 14, 2011

Study Record Updates

• Last Update Posted (Actual): February 4, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Contraception; NuvaRing
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; NuvaRing
• Other Study ID Numbers: P06450

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Study Data/Documents

1. CSR Synopsis