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

NCT01277211 | Completed Phase 3 Results

• 1 other identifier: P06450
• Study Type: interventional
• Target: 983
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Contraception

Keywords

Contraception; NuvaRing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percentage of Participants With Intermenstrual (Breakthrough) Bleeding/Spotting, by Cycle

  Up to 1 year

• Percentage of Participants With Absence of Withdrawal Bleeding, by Cycle

  Up to 1 year

Study Arms (2)

ENG-EE (NuvaRing)

EXPERIMENTAL

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

DRSP-EE

ACTIVE COMPARATOR

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

Interventions

ENG 120 µg + EE 15 µg intravaginal ring DRUG

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.

Also known as: NuvaRing

ENG-EE (NuvaRing)

DRSP 3 mg + EE 30 µg DRUG

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.

Also known as: Yasmin

DRSP-EE

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

Related 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 randomised trial. Eur J Contracept Reprod Health Care. 2016 Aug;21(4):303-9. doi: 10.1080/13625187.2016.1186269. Epub 2016 Jun 24.

  PMID: 27339759 RESULT

MeSH Terms

Interventions

Endoglin; NuvaRing; drospirenone; drospirenone and ethinyl estradiol combination

Intervention Hierarchy (Ancestors)

Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharpe & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2011
• First Posted: January 14, 2011
• Study Start: September 19, 2011
• Primary Completion: September 18, 2013
• Study Completion: September 18, 2013
• Last Updated: June 20, 2024
• Results First Posted: September 15, 2014

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share