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

Organon

Status and phase: Completed; Phase 2

Conditions: Dysmenorrhea

Treatments: Drug: Ibuprofen; Drug: Nomegestrol acetate contraceptive vaginal ring (NOMAC-CVR); Drug: Etonogestrel containing contraceptive vaginal ring (ENG-CVR); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01670656

MK-8175A/MK-8342B-057 (Other Identifier)

P08257

2012-002449-40 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 439 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) ≥18 and ≤35
• Established diagnosis of primary dysmenorrhea
• If of child-bearing potential must agree to use condoms for contraception during the entire screening period, treatment period, and post-treatment period until the final study visit, unless she or her partner are surgically sterilized
• Agree to stop using hormonal contraceptive (combined or progestin-only), or a non hormonal intrauterine device (IUD)
• Regular menstrual cycles ranging from 24 to 35 days in length

Exclusion criteria

• Any of the following contraindications to the use of contraceptive steroids including: presence or a history of venous or arterial thrombotic/thromboembolic events or cerebrovascular accident (stroke, history of migraine with focal neurological symptoms, diabetes mellitus with vascular involvement, severe or multiple risk factor(s) for venous or arterial thrombosis, severe dyslipoproteinemia, severe hypertension, pancreatitis or a history thereof if associated with severe hypertriglyceridaemia, presence or history of severe hepatic (liver) disease, including benign or malignant tumors, known or suspected sex steroid-influenced malignancies, and/or undiagnosed vaginal bleeding
• Pregnant or breastfeeding
• Secondary dysmenorrhea
• Has not had spontaneous menstruation following a delivery or abortion
• Participated in an investigational drug study within 30 days
• History of malignancy ≤5 years
• Documented abnormal cervical smear result within 6 months
• Use of recreational or illicit drugs
• Consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking
• Allergy/sensitivity to ibuprofen, or any contraindication to its use, or has experienced asthma, urticaria, or allergic-type reactions after taking aspirin, or other nonsteroidal anti inflammatory drugs
• Has been sterilized using a fallopian tube occlusion device
• Is receiving, or has received sex hormones for any purpose other than contraception within 2 months or injectable hormonal contraception within 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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439 participants in 5 patient groups, including a placebo group

NOMAC-E2 700/300 mcg

Experimental group

Description:

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.

Treatment:

Drug: Ibuprofen

Drug: Nomegestrol acetate contraceptive vaginal ring (NOMAC-CVR)

NOMAC-E2 900/300 mcg

Experimental group

Description:

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.

Treatment:

Drug: Ibuprofen

Drug: Nomegestrol acetate contraceptive vaginal ring (NOMAC-CVR)

ENG-E2 100/300 mcg

Experimental group

Description:

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.

Treatment:

Drug: Etonogestrel containing contraceptive vaginal ring (ENG-CVR)

Drug: Ibuprofen

ENG-E2 125/300 mcg

Experimental group

Description:

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.

Treatment:

Drug: Etonogestrel containing contraceptive vaginal ring (ENG-CVR)

Drug: Ibuprofen

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: Ibuprofen