Conditions: Dysmenorrhea
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 439
Healthy volunteers: no

Brief summary:
The study investigates four vaginal ring groups with respect to relief of primary dysmenorrhea, and should identify at least one vaginal ring that shows clinically relevant treatment efficacy in relief of primary dysmenorrhea.

Detailed description:
The study investigates four vaginal ring groups with respect to relief of primary dysmenorrhea, and should identify at least one vaginal ring that shows clinically relevant treatment efficacy in relief of primary dysmenorrhea. The intake of ibuprofen rescue medication and the impact on daily life is investigated: change from baseline data of these two variables will be compared between each of the four active ring groups, separately, and the placebo ring group. Furthermore, the study assesses the measurement characteristics and psychometric properties of a newly developed Dysmenorrhea Daily Dairy. Vaginal bleeding pattern and general safety and tolerability will also be evaluated.

Arms:
arm 1: NOMAC-E2 700/300 mcg will be administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. arm 2: NOMAC-E2 900/300 mcg will be administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. arm 3: ENG-E2 100/300 mcg will be administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. arm 4: ENG-E2 125/300 mcg will be administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. arm 5: Placebo will be administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.

Interventions: intervention 1: Nomegestrol acetate contraceptive vaginal ring (NOMAC-CVR) intervention 2: Etonogestrel containing contraceptive vaginal ring (ENG-CVR) intervention 3: Placebo intervention 4: Ibuprofen
Intervention descriptions: intervention 1: Either 700 or 900 mcg NOMAC and 300 mcg E2 intravaginal ring for two 28-day cycles intervention 2: Either 100 or 125 mcg ENG and 300 mcg E2, intravaginally for two 28-day cycles intervention 3: Placebo to match vaginal ring, intravaginally for two 28-day cycles intervention 4: 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)

Protocol document: