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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01670656
First received: August 14, 2012
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Dysmenorrhea
Drug: Nomegestrol acetate contraceptive vaginal ring (NOMAC-CVR)
Drug: Etonogestrel containing contraceptive vaginal ring (ENG-CVR)
Drug: Placebo
Drug: Ibuprofen
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Partially Blinded, Placebo-controlled Clinical Trial to Evaluate the Effect on Primary Dysmenorrhea of Vaginal Rings With an Average Daily Release of 700 μg Nomegestrol Acetate (NOMAC) and 300 μg Estradiol (E2), or 900 μg Nomegestrol Acetate (NOMAC) and 300 μg Estradiol (E2), or 100 μg Etonogestrel (ENG) and 300 μg E2, or 125 μg Etonogestrel (ENG) and 300 μg E2. Protocol MK-8175A/MK-8342B 057 (Abbreviated as P057), Also Known as SCH900121/SCH900432 08257 (Abbreviated as P08257)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change in Mean Menstrual Cramping Pain Score [ Time Frame: Baseline to End of Cycle 2 (Day 56) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Mean Total Impact Score [ Time Frame: Baseline to End of Cycle 2 (Day 56) ] [ Designated as safety issue: No ]
  • Change in Number of Ibuprofen Tablets [ Time Frame: Baseline to End of Cycle 2 (Day 56) ] [ Designated as safety issue: No ]
  • Change in Number of Days of Ibuprofen Intake [ Time Frame: Baseline to End of Cycle 2 (Day 56) ] [ Designated as safety issue: No ]

Enrollment: 439
Study Start Date: January 2013
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 700 μg NOMAC/300 μg E2
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)
Either 700 or 900 μg NOMAC and 300 μg E2 intravaginal ring for two 28-day cycles
Other Names:
  • SCH900121
  • MK-8175A
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)
Other Name: Motrin
Experimental: 900 μg NOMAC/300 μg E2
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)
Either 700 or 900 μg NOMAC and 300 μg E2 intravaginal ring for two 28-day cycles
Other Names:
  • SCH900121
  • MK-8175A
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)
Other Name: Motrin
Experimental: 100 μg ENG/300 μg E2
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)
Either 100 or 125 μg ENG and 300 μg E2, intravaginally for two 28-day cycles
Other Names:
  • SCH900432
  • MK-8342B
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)
Other Name: Motrin
Experimental: 125 μg ENG/300 μg E2
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)
Either 100 or 125 μg ENG and 300 μg E2, intravaginally for two 28-day cycles
Other Names:
  • SCH900432
  • MK-8342B
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)
Other Name: Motrin
Placebo Comparator: Placebo
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
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)
Other Name: Motrin

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01670656     History of Changes
Other Study ID Numbers: P08257, 2012-002449-40, MK-8175A/MK-8342B-057
Study First Received: August 14, 2012
Last Updated: October 18, 2013
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Additional relevant MeSH terms:
Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Signs and Symptoms
Ibuprofen
Contraceptive Agents
3-keto-desogestrel
Megestrol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 16, 2014