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
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 April 17, 2014