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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraception

Intervention: Ethinylestradiol + Etonogestrel Vaginal Ring (NuvaRing) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

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.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome:

Number of Participants With Regular Menstrual Cycles

Average Number of Bleeding Days Per Cycle

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

Number of Participants With Intermenstrual Bleeding/Spotting

Number of Bleeding Days Per Cycle

Number of Spotting Days Per Cycle

Participants' Assessment of Ease of Insertion of Vaginal Ring

Participants' Assessment of Ease of Removal of Vaginal Ring

Participants' Assessment of Feeling Vaginal Ring at Any Time

Participants' Assessment of Feeling Vaginal Ring During Intercourse

Frequency of Partner Feeling Vaginal Ring During Intercourse

Frequency of Partner Objecting to Vaginal Ring Use

Participants' Overall Satisfaction With Vaginal Ring

Number of Participants Who Plan to Continue Using Vaginal Ring

Number of Participants Who Would Recommend Vaginal Ring to Others

Secondary outcome:

Number of Pregnancies Due to Contraceptive Method Failure During the Study

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

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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

Locations and Contacts

MSD Pharmaceuticals Private Ltd., Gurgaon 122002, India
Additional Information

Starting date: December 2011
Last updated: June 8, 2015

Page last updated: August 23, 2015

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