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

Organon

Status and phase: Completed; Phase 3

Conditions: Contraception

Treatments: Drug: ENG 120 µg + EE 15 µg intravaginal ring; Drug: DRSP 3 mg + EE 30 µg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01277211

P06450

Details and patient eligibility

About

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.

Full 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.

Enrollment: 983 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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983 participants in 2 patient groups

ENG-EE (NuvaRing)

Experimental group

Description:

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.

Treatment:

Drug: ENG 120 µg + EE 15 µg intravaginal ring

DRSP-EE

Active Comparator group

Description:

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.

Treatment:

Drug: DRSP 3 mg + EE 30 µg