NCT01670656View on ClinicalTrials.gov

A Study to Evaluate the Effect of Contraceptive Vaginal Rings on Primary Dysmenorrhea (P08257/MK-8175A/MK-8342B-057)

PHASE2CompletedINTERVENTIONAL
Enrollment

439

Participants

Timeline

Start Date

January 21, 2013

Primary Completion Date

September 11, 2013

Study Completion Date

September 12, 2013

Conditions
Dysmenorrhea
Interventions
DRUG

Nomegestrol acetate contraceptive vaginal ring (NOMAC-CVR)

Either 700 or 900 mcg NOMAC and 300 mcg E2 intravaginal ring for two 28-day cycles

DRUG

Etonogestrel containing contraceptive vaginal ring (ENG-CVR)

Either 100 or 125 mcg ENG and 300 mcg E2, intravaginally for two 28-day cycles

DRUG

Placebo

Placebo to match vaginal ring, intravaginally for two 28-day cycles

DRUG

Ibuprofen

Ibuprofen 400 mg will be dispensed throughout the entire study as needed as rescue medication for treating menstrual cramping pain. The maximum daily ibuprofen dose is 3200 mg (8 tablets)

All Listed Sponsors
lead

Organon and Co

INDUSTRY

NCT01670656 - A Study to Evaluate the Effect of Contraceptive Vaginal Rings on Primary Dysmenorrhea (P08257/MK-8175A/MK-8342B-057) | Biotech Hunter | Biotech Hunter