Phase 4 N=252 Prevention

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

Contraception

Bottom Line

View on ClinicalTrials.gov: NCT01490190 ↗

Enrolled (actual)

252

Serious AEs

0.0%

Results posted

Jan 2014

Primary outcome: Primary: Number of Participants With Regular Menstrual Cycles — 192; 9; 3; 199 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Ethinylestradiol + Etonogestrel Vaginal Ring (NuvaRing) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Organon and Co
Primary completion: Dec 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Regular Menstrual Cycles	192; 9; 3; 199; 4; 1	—
PRIMARY Average Number of Bleeding Days Per Cycle	3.8; 3.7; 3.6	—
PRIMARY Average Number of Pads Used Per Day, Per Cycle, During Menstruation While Using Ring	2; 2; 2	—
PRIMARY Number of Participants With Intermenstrual Bleeding/Spotting	5; 1; 4; 0; 0; 0	—
PRIMARY Number of Bleeding Days Per Cycle	4; 0; 0	—
PRIMARY Number of Spotting Days Per Cycle	5.5; 0; 3	—
PRIMARY Participants' Assessment of Ease of Insertion of Vaginal Ring	59; 82; 59; 4; 0; 0	—
PRIMARY Participants' Assessment of Ease of Removal of Vaginal Ring	70; 128; 6; 0; 0; 0	—
PRIMARY Participants' Assessment of Feeling Vaginal Ring at Any Time	87; 89; 25; 1; 2; 107	—
PRIMARY Participants' Assessment of Feeling Vaginal Ring During Intercourse	85; 81; 33; 3; 2; 100	—
PRIMARY Frequency of Partner Feeling Vaginal Ring During Intercourse	88; 75; 34; 5; 2; 112	—
PRIMARY Frequency of Partner Objecting to Vaginal Ring Use	129; 70; 4; 1; 0; 143	—
PRIMARY Participants' Overall Satisfaction With Vaginal Ring	68; 119; 28; 9; 1; 27	—
PRIMARY Number of Participants Who Plan to Continue Using Vaginal Ring	216; 9; 27; 205; 5; 3	—
PRIMARY Number of Participants Who Would Recommend Vaginal Ring to Others	208; 16; 28; 197; 13; 3	—
SECONDARY Number of Pregnancies Due to Contraceptive Method Failure During the Study	0; 226; 26; 0; 210; 3	—
SECONDARY Number of Participants Who Reported at Least One Adverse Event During the Study	47	—
SECONDARY Number of Participants Who Reported a Serious Adverse Event During the Study	—	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01490190). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.