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

Organon and Co983 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

983

Conditions

Contraception

Interventions

ENG 120 µg + EE 15 µg intravaginal ringDRUG

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 µgDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).

Time frame: Up to 1 year

Secondary Outcomes

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.

Time frame: 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.

Time frame: Up to 1 year

Data from ClinicalTrials.gov

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