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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01490190
First received: November 22, 2011
Last updated: February 5, 2014
Last verified: February 2014
  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:


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

Primary Outcome Measures:
  • Number of Participants With Regular Menstrual Cycles [ Time Frame: Up to 84 days (three 28-day cycles) ] [ Designated as safety issue: No ]
    The number of participants who experienced regular menstrual bleeding patterns throughout the period of NuvaRing use. Bleeding patterns were to be characterized by particpants as regular or irregular.

  • Average Number of Bleeding Days Per Cycle [ Time Frame: Up to 84 days (three 28-day cycles) ] [ Designated as safety issue: No ]
    Mean duration of menstruation, per day, per cycle, during the study period.

  • Average Number of Pads Used Per Day, Per Cycle, During Menstruation While Using Ring [ Time Frame: Up to 84 days (three 28-day cycles) ] [ Designated as safety issue: No ]
    Intensity of menstruation, as indicated by the median number of pads used per day by participants during each cycle of NuvaRing use.

  • Number of Participants With Intermenstrual Bleeding/Spotting [ Time Frame: Up to 84 days (three 28-day cycles) ] [ Designated as safety issue: No ]
    Number of participants who experienced vaginal bleeding, which includes BLEEDING or SPOTTING, at any time during a cycle other than normal menstruation while in the study. Vaginal bleeding that required >=2 pads per day was classified as BLEEDING. Vaginal bleeding that required <=1 pad per day was classified as SPOTTING.

  • Number of Bleeding Days Per Cycle [ Time Frame: Up to 84 days (three 28-day cycles) ] [ Designated as safety issue: No ]
    Intermenstrual vaginal bleeding that required >=2 pads per day was classified as BLEEDING.

  • Number of Spotting Days Per Cycle [ Time Frame: Up to 84 days (three 28-day cycles) ] [ Designated as safety issue: No ]
    Intermenstrual vaginal bleeding that required <=1 pad per day was classified as SPOTTING.

  • Participants' Assessment of Ease of Insertion of Vaginal Ring [ Time Frame: Up to 84 days (three 28-day cycles) ] [ Designated as safety issue: No ]
    Participants were asked to classify their ability to insert the NuvaRing as very easy, easy, neutral, difficult, very difficult, or failed. The number of participants who responded to each category was reported.

  • Participants' Assessment of Ease of Removal of Vaginal Ring [ Time Frame: Up to 84 days (three 28-day cycles) ] [ Designated as safety issue: No ]
    Participants were asked to classify their ability to remove the NuvaRing as very easy, easy, neutral, difficult, very difficult, or failed. The number of participants who responded to each category was reported.

  • Participants' Assessment of Feeling Vaginal Ring at Any Time [ Time Frame: Up to 84 days (three 28-day cycles) ] [ Designated as safety issue: No ]
    Participants were asked to assess whether they could feel the NuvaRing at any time and to characterize how often as one of the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported.

  • Participants' Assessment of Feeling Vaginal Ring During Intercourse [ Time Frame: Up to 84 days (three 28-day cycles) ] [ Designated as safety issue: No ]
    Participants were asked to assess whether they could feel the NuvaRing during intercourse and to characterize how often as one the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported.

  • Frequency of Partner Feeling Vaginal Ring During Intercourse [ Time Frame: Up to 84 days (three 28-day cycles) ] [ Designated as safety issue: No ]
    Participants were asked if their partners could feel the NuvaRing during intercourse and to characterize their partners' experience as one of the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported.

  • Frequency of Partner Objecting to Vaginal Ring Use [ Time Frame: Up to 84 days (three 28-day cycles) ] [ Designated as safety issue: No ]
    Participants were asked if their partners objected to their using the NuvaRing during intercourse and to characterize the frequency of their partners' objections as one of the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported.

  • Participants' Overall Satisfaction With Vaginal Ring [ Time Frame: Up to 84 days (three 28-day cycles) ] [ Designated as safety issue: No ]
    Participants were asked to characterize their overall satisfaction with the NuvaRing as one of the following: very satisfied, satisfied, neutral, unsatisfied, or very unsatisfied. The number of participants who responded to each category was reported.

  • Number of Participants Who Plan to Continue Using Vaginal Ring [ Time Frame: Up to 84 days (three 28-day cycles) ] [ Designated as safety issue: No ]
    Participants were asked at follow-up visits after every cycle whether they planned to continue using NuvaRing, and their answers were recorded.

  • Number of Participants Who Would Recommend Vaginal Ring to Others [ Time Frame: Up to 84 days (three 28-day cycles) ] [ Designated as safety issue: No ]
    Participants were asked at follow-up visits after every cycle whether they would recommend NuvaRing to other women, and their answers were reported.


Secondary Outcome Measures:
  • Number of Pregnancies Due to Contraceptive Method Failure During the Study [ Time Frame: Up to 84 days (three 28-day cycles) ] [ Designated as safety issue: No ]
    For participants with suspected pregnancy during in-treatment period, pregnancy was to be confirmed by hCG qualitative analysis using strip and/or other test(s) at the discretion of the treating physician.

  • Number of Participants Who Reported at Least One Adverse Event During the Study [ Time Frame: Up to 84 days (three 28-day cycles) ] [ Designated as safety issue: Yes ]
    An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic, or medical device, which does not necessarily have a causal relationship with the treatment.

  • Number of Participants Who Reported a Serious Adverse Event During the Study [ Time Frame: Up to 84 days (three 28-day cycles) ] [ Designated as safety issue: Yes ]
    A serious adverse event is any adverse drug or biologic or device experience that results in death, a life-threatening adverse event, persistent or significant disability or incapacity; requires in-patient hospitalization, or prolonged hospitalization; or causes a congenital anomaly or birth defect.


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: NuvaRing 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
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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01490190

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01490190     History of Changes
Other Study ID Numbers: P07733, CTRI/2011/11/002098
Study First Received: November 22, 2011
Results First Received: November 25, 2013
Last Updated: February 5, 2014
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
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Progestins

ClinicalTrials.gov processed this record on July 31, 2014