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

NCT ID: NCT01670656

Last Updated: 2024-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 439 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-21
• Study Completion Date: 2013-09-12

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.

Conditions

Dysmenorrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

NOMAC-E2 700/300 mcg

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.

Group Type: EXPERIMENTAL

Nomegestrol acetate contraceptive vaginal ring (NOMAC-CVR)

Intervention Type: DRUG

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

Ibuprofen

Intervention Type: DRUG

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)

NOMAC-E2 900/300 mcg

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.

Group Type: EXPERIMENTAL

Nomegestrol acetate contraceptive vaginal ring (NOMAC-CVR)

Intervention Type: DRUG

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

Ibuprofen

Intervention Type: DRUG

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)

ENG-E2 100/300 mcg

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.

Group Type: EXPERIMENTAL

Etonogestrel containing contraceptive vaginal ring (ENG-CVR)

Intervention Type: DRUG

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

Ibuprofen

Intervention Type: DRUG

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)

ENG-E2 125/300 mcg

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.

Group Type: EXPERIMENTAL

Etonogestrel containing contraceptive vaginal ring (ENG-CVR)

Intervention Type: DRUG

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

Ibuprofen

Intervention Type: DRUG

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)

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Ibuprofen

Intervention Type: DRUG

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)

Interventions

Nomegestrol acetate contraceptive vaginal ring (NOMAC-CVR)

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

Intervention Type: DRUG

Etonogestrel containing contraceptive vaginal ring (ENG-CVR)

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

Intervention Type: DRUG

Placebo

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

Intervention Type: 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)

Intervention Type: DRUG

Other Intervention Names

SCH900121; MK-8175A; SCH900432; MK-8342B; Motrin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Fox MC, Klipping C, Nguyen AM, Frenkl TL, Cruz SM, Wang Y, Korver T. A phase 2b multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of vaginal rings containing nomegestrol acetate or etonogestrel and 17beta-estradiol in the treatment of women with primary dysmenorrhea. Contraception. 2019 Feb;99(2):125-130. doi: 10.1016/j.contraception.2018.10.009. Epub 2018 Nov 12.

Reference Type: DERIVED

PMID: 30439359 (View on PubMed)

Other Identifiers

2012-002449-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MK-8175A/MK-8342B-057

Identifier Type: OTHER

Identifier Source: secondary_id

P08257

Identifier Type: -

Identifier Source: org_study_id