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

NCT01490190 | Completed Phase 4 Results

• 2 other identifiers: P07733CTRI/2011/11/002098
• Study Type: interventional
• Target: 252
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Contraception

Outcome Measures

Primary Outcomes (15)

• Number of Participants With Regular Menstrual 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.

  Up to 84 days (three 28-day cycles)

• Average Number of Bleeding Days Per Cycle

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

  Up to 84 days (three 28-day cycles)

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

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

  Up to 84 days (three 28-day cycles)

• Number of Participants With Intermenstrual Bleeding/Spotting

  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.

  Up to 84 days (three 28-day cycles)

• Number of Bleeding Days Per Cycle

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

  Up to 84 days (three 28-day cycles)

• Number of Spotting Days Per Cycle

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

  Up to 84 days (three 28-day cycles)

• Participants' Assessment of Ease of Insertion of Vaginal Ring

  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.

  Up to 84 days (three 28-day cycles)

• Participants' Assessment of Ease of Removal of Vaginal Ring

  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.

  Up to 84 days (three 28-day cycles)

• Participants' Assessment of Feeling Vaginal Ring at Any Time

  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.

  Up to 84 days (three 28-day cycles)

• Participants' Assessment of Feeling Vaginal Ring During Intercourse

  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.

  Up to 84 days (three 28-day cycles)

• Frequency of Partner Feeling Vaginal Ring During Intercourse

  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.

  Up to 84 days (three 28-day cycles)

• Frequency of Partner Objecting to Vaginal Ring Use

  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.

  Up to 84 days (three 28-day cycles)

• Participants' Overall Satisfaction With Vaginal Ring

  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.

  Up to 84 days (three 28-day cycles)

• Number of Participants Who Plan to Continue Using Vaginal Ring

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

  Up to 84 days (three 28-day cycles)

• Number of Participants Who Would Recommend Vaginal Ring to Others

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

  Up to 84 days (three 28-day cycles)

Secondary Outcomes (3)

• Number of Pregnancies Due to Contraceptive Method Failure During the Study

  Up to 84 days (three 28-day cycles)

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

  Up to 84 days (three 28-day cycles)

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

  Up to 84 days (three 28-day cycles)

Study Arms (1)

NuvaRing

EXPERIMENTAL

Drug: Ethinylestradiol + Etonogestrel Vaginal Ring (NuvaRing)

Interventions

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.

Also known as: NuvaRing, SCH 900702

NuvaRing

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women at risk of pregnancy and seeking contraception

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Interventions

Ethinyl Estradiol; NuvaRing

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: December 12, 2011
• Study Start: December 26, 2011
• Primary Completion: December 5, 2012
• Study Completion: December 5, 2012
• Last Updated: May 24, 2024
• Results First Posted: January 14, 2014

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share