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Study of the Use of a Contraceptive Vaginal Ring (NuvaRing) in Normal Daily Practice in Indian Women (P07733 AM1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01490190
First received: November 22, 2011
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
  Purpose

This study will collect information on cycle control, acceptability and tolerability of the vaginal contraceptive ring (NuvaRing) as used in normal daily practice by Indian women.


Condition Intervention Phase
Contraception
 Drug: Ethinylestradiol + Etonogestrel Vaginal Ring (NuvaRing)
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Contraceptive Vaginal Ring Releasing Etonogestrel and Ethinylestradiol (NuvaRing): Cycle Control, Acceptability and Tolerability Study in Indian Women

Resource links provided by NLM:

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Number of participants with regular menstrual cycles [ Time Frame: 84 days (three 28-day cycles) ] [ Designated as safety issue: No ]
  • Average number of bleeding days [ Time Frame: 84 days (three 28-day cycles) ] [ Designated as safety issue: No ]
  • Average number of pads used per day [ Time Frame: 84 days (three 28-day cycles) ] [ Designated as safety issue: No ]
  • Number of participants with breakthrough bleeding/spotting [ Time Frame: 84 days (three 28-day cycles) ] [ Designated as safety issue: No ]
  • Number of bleeding/spotting days [ Time Frame: 84 days (three 28-day cycles) ] [ Designated as safety issue: No ]
  • Participants' assessment of ease of insertion (very easy, easy, neutral, difficult, very difficult, and failed) [ Time Frame: 84 days (three 28-day cycles) ] [ Designated as safety issue: No ]
  • Participants' assessment of ease of removal (very easy, easy, neutral, difficult, very difficult, and failed) [ Time Frame: 84 days (three 28-day cycles) ] [ Designated as safety issue: No ]
  • Participants' assessment of feeling ring at any time (never, rarely, occasionally, mostly, always) [ Time Frame: 84 days (three 28-day cycles) ] [ Designated as safety issue: No ]
  • Participants' assessment of feeling ring during intercourse (never, rarely, occasionally, mostly, always) [ Time Frame: 84 days (three 28-day cycles) ] [ Designated as safety issue: No ]
  • Frequency of partner feeling ring during intercourse (never, rarely, occasionally, mostly, always) [ Time Frame: 84 days (three 28-day cycles) ] [ Designated as safety issue: No ]
  • Frequency of partner objection to ring use (never, rarely, occasionally, mostly, always) [ Time Frame: 84 days (three 28-day cycles) ] [ Designated as safety issue: No ]
  • Participants' overall satisfaction with ring (very satisfied, satisfied, neutral, unsatisfied, very unsatisfied) [ Time Frame: 84 days (three 28-day cycles) ] [ Designated as safety issue: No ]
  • Number of participants who plan to continue use of ring [ Time Frame: 84 days (three 28-day cycles) ] [ Designated as safety issue: No ]
  • Number of participants who would recommend ring to others [ Time Frame: 84 days (three 28-day cycles) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of pregnancies due to contraceptive method failure during the study [ Time Frame: 84 days (three 28-day cycles) ] [ Designated as safety issue: No ]
  • Number of adverse events reported during the study [ Time Frame: 84 days (three 28-day cycles) ] [ Designated as safety issue: Yes ]
  • Number of serious adverse events during the study [ Time Frame: 84 days (three 28-day cycles) ] [ Designated as safety issue: Yes ]

Enrollment: 252
Study Start Date: December 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All Participants Drug: Ethinylestradiol + Etonogestrel Vaginal Ring (NuvaRing)
Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
Other Names:
  • NuvaRing
  • SCH 900702

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women at risk of pregnancy and seeking contraception

Exclusion Criteria:

Exclusion criteria based on approved prescribing information in India:

  • Presence or history of venous thrombosis, with or without pulmonary embolism.
  • Presence or history of arterial thrombosis (e.g. cerebrovascular accident, myocardial infarction) or prodromi of a thrombosis (e.g. angina pectoris or transient ischemic attack).
  • Known predisposition for venous or arterial thrombosis, with or without hereditary involvement such as Activated Protein C (APC) resistance, antithrombin-III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
  • History of migraine with focal neurological symptoms.
  • Diabetes mellitus with vascular involvement.
  • The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis (at the discretion of the doctors)
  • Pancreatitis or a history thereof if associated with severe hypertriglyceridemia.
  • Presence or history of severe hepatic disease as long as liver function values have not returned to normal.
  • Presence or history of liver tumors (benign or malignant).
  • Known or suspected malignant conditions of the genital organs or the breasts, if sex steroid-influenced.
  • Undiagnosed vaginal bleeding.
  • Known or suspected pregnancy.
  • Hypersensitivity to the active substances or to any of the excipients of NuvaRing.
  • Women who are breast feeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01490190

Locations
India
MSD Pharmaceuticals Private Ltd.
Gurgaon, India, 122002
Sponsors and Collaborators
Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01490190     History of Changes
Other Study ID Numbers: P07733
Study First Received: November 22, 2011
Last Updated: January 16, 2013
Health Authority: India: Drugs Controller General of India

Additional relevant MeSH terms:
Contraceptive Agents
3-keto-desogestrel
Desogestrel
Ethinyl Estradiol
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
 Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Progestins
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on May 22, 2013