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

NCT01670656 | Completed Phase 2 Results

• 3 other identifiers: P082572012-002449-40MK-8175A/MK-8342B-057
• Study Type: interventional
• Target: 439
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dysmenorrhea

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Mean Menstrual Cramping Pain Score Through Cycle 2

  The Mean Menstrual Cramping Pain score was calculated as the average of the three highest daily menstrual cramping scores (item #3 of the Menstrual Distress Questionnaire: "Cramps") in the baseline cycle and treatment Cycle 2, respectively. The daily menstrual cramping pain score was based on five pain categories: none (0); mild (1); moderate (2); strong (3); and severe (4). In case of absence of withdrawal bleeding, or onset of menstruation, the mean of the three highest menstrual cramping pain scores recorded within Days 21-28 was used for analysis. The Mean Menstrual Cramping Pain Score in the baseline or subsequent cycles could range from 0 (none) to 4 (severe).

  Baseline and Day 29 to 56 (Cycle 2)

Secondary Outcomes (3)

• Change From Baseline in Total Mean Impact Score Through Cycle 2

  Baseline and Day 29 to 56 (Cycle 2)

• Change From Baseline in Number of Ibuprofen Tablets Taken Through Cycle 2

  Baseline and Day 29 to 56 (Cycle 2)

• Change From Baseline in Number of Days of Ibuprofen Intake Through Cycle 2

  Baseline and Day 29 to 56 (Cycle 2)

Study Arms (5)

NOMAC-E2 700/300 mcg

EXPERIMENTAL

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.

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

NOMAC-E2 900/300 mcg

EXPERIMENTAL

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.

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

ENG-E2 100/300 mcg

EXPERIMENTAL

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.

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

ENG-E2 125/300 mcg

EXPERIMENTAL

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.

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

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo; Drug: Ibuprofen

Interventions

Nomegestrol acetate contraceptive vaginal ring (NOMAC-CVR) DRUG

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

Also known as: SCH900121, MK-8175A

NOMAC-E2 700/300 mcg; NOMAC-E2 900/300 mcg

Etonogestrel containing contraceptive vaginal ring (ENG-CVR) DRUG

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

Also known as: SCH900432, MK-8342B

ENG-E2 100/300 mcg; ENG-E2 125/300 mcg

Placebo DRUG

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

Placebo

Ibuprofen 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)

Also known as: Motrin

ENG-E2 100/300 mcg; ENG-E2 125/300 mcg; NOMAC-E2 700/300 mcg; NOMAC-E2 900/300 mcg; Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• 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.

  PMID: 30439359 DERIVED

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2012
• First Posted: August 22, 2012
• Study Start: January 21, 2013
• Primary Completion: September 11, 2013
• Study Completion: September 12, 2013
• Last Updated: May 28, 2024
• Results First Posted: August 24, 2017

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share