A Study to Evaluate the Effectiveness of NuvaRing® to Prevent Pregnancies in Chinese Women (P06450 AM5)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01277211
First received: January 12, 2011
Last updated: October 4, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Contraception
Drug: ENG 120 µg/EE 15 µg intravaginal ring
Drug: DRSP 3 mg/EE 30 µg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • The number of in-treatment pregnancies per 100 woman-years of exposure (Pearl Index) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of breakthrough bleeding/spotting [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Absence of withdrawal bleeding [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 983
Study Start Date: September 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Etonogestrel (ENG) 120 µg/Ethinylestradiol (EE) 15 µg Drug: ENG 120 µg/EE 15 µg intravaginal ring
Etonogestrel (ENG) 120 µg/Ethinylestradiol (EE) 15 µg over a period of 3 weeks. One cycle consists of 21-days of NuvaRing use followed by a ring-free week. NuvaRing will be used for 13 cycles of 28 days.
Other Name: NuvaRing
Active Comparator: Drospirenone (DRSP) 3 mg-Ethinylestradiol (EE) 30 µg Drug: DRSP 3 mg/EE 30 µg
DRSP 3 mg/EE 30 µg will be taken for 13 cycles of 28 days, each cycle consisting of: One tablet daily for 21 consecutive days followed by 7 tablet-free days
Other Name: Yasmin

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01277211     History of Changes
Other Study ID Numbers: P06450
Study First Received: January 12, 2011
Last Updated: October 4, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Contraception
NuvaRing

Additional relevant MeSH terms:
Ethinyl Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 25, 2014