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OpenTrials
Completed

NCT Number: NCT01490190

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

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.

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Key information

Conditions

Contraception

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ethinylestradiol + Etonogestrel Vaginal Ring (NuvaRing)

Drug

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

Primary outcomes

  1. Number of Participants With Regular Menstrual Cycles

    Time frame: Up to 84 days (three 28-day cycles)

    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.

  2. Average Number of Bleeding Days Per Cycle

    Time frame: Up to 84 days (three 28-day cycles)

    Mean duration of menstruation, per day, per cycle, during the study period.

  3. Average Number of Pads Used Per Day, Per Cycle, During Menstruation While Using Ring

    Time frame: Up to 84 days (three 28-day cycles)

    Intensity of menstruation, as indicated by the median number of pads used per day by participants during each cycle of NuvaRing use.

  4. Number of Participants With Intermenstrual Bleeding/Spotting

    Time frame: Up to 84 days (three 28-day cycles)

    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.

  5. Number of Bleeding Days Per Cycle

    Time frame: Up to 84 days (three 28-day cycles)

    Intermenstrual vaginal bleeding that required >=2 pads per day was classified as BLEEDING.

  6. Number of Spotting Days Per Cycle

    Time frame: Up to 84 days (three 28-day cycles)

    Intermenstrual vaginal bleeding that required <=1 pad per day was classified as SPOTTING.

  7. Participants' Assessment of Ease of Insertion of Vaginal Ring

    Time frame: Up to 84 days (three 28-day cycles)

    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.

  8. Participants' Assessment of Ease of Removal of Vaginal Ring

    Time frame: Up to 84 days (three 28-day cycles)

    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.

  9. Participants' Assessment of Feeling Vaginal Ring at Any Time

    Time frame: Up to 84 days (three 28-day cycles)

    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.

  10. Participants' Assessment of Feeling Vaginal Ring During Intercourse

    Time frame: Up to 84 days (three 28-day cycles)

    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.

  11. Frequency of Partner Feeling Vaginal Ring During Intercourse

    Time frame: Up to 84 days (three 28-day cycles)

    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.

  12. Frequency of Partner Objecting to Vaginal Ring Use

    Time frame: Up to 84 days (three 28-day cycles)

    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.

  13. Participants' Overall Satisfaction With Vaginal Ring

    Time frame: Up to 84 days (three 28-day cycles)

    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.

  14. Number of Participants Who Plan to Continue Using Vaginal Ring

    Time frame: Up to 84 days (three 28-day cycles)

    Participants were asked at follow-up visits after every cycle whether they planned to continue using NuvaRing, and their answers were recorded.

  15. Number of Participants Who Would Recommend Vaginal Ring to Others

    Time frame: Up to 84 days (three 28-day cycles)

    Participants were asked at follow-up visits after every cycle whether they would recommend NuvaRing to other women, and their answers were reported.

Secondary outcomes

  1. Number of Pregnancies Due to Contraceptive Method Failure During the Study

    Time frame: Up to 84 days (three 28-day cycles)

    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.

  2. Number of Participants Who Reported at Least One Adverse Event During the Study

    Time frame: Up to 84 days (three 28-day cycles)

    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.

  3. Number of Participants Who Reported a Serious Adverse Event During the Study

    Time frame: Up to 84 days (three 28-day cycles)

    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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

Contraceptive Vaginal Ring Releasing Etonogestrel and Ethinylestradiol (NuvaRing): Cycle Control, Acceptability and Tolerability Study in Indian Women

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 12, 2011
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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