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 17, 2014
Last verified: October 2014

August 14, 2012
October 17, 2014
January 2013
September 2013   (final data collection date for primary outcome measure)
Change in Mean Menstrual Cramping Pain Score [ Time Frame: Baseline to End of Cycle 2 (Day 56) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01670656 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Effect of Vaginal Rings on Primary Dysmenorrhea (P08257/MK-8175A/MK-8342B-057)
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)

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 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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Dysmenorrhea
  • 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: 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: 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
  • 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
    Interventions:
    • Drug: Nomegestrol acetate contraceptive vaginal ring (NOMAC-CVR)
    • Drug: Ibuprofen
  • 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
    Interventions:
    • Drug: Nomegestrol acetate contraceptive vaginal ring (NOMAC-CVR)
    • Drug: Ibuprofen
  • 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
    Interventions:
    • Drug: Etonogestrel containing contraceptive vaginal ring (ENG-CVR)
    • Drug: Ibuprofen
  • 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
    Interventions:
    • Drug: Etonogestrel containing contraceptive vaginal ring (ENG-CVR)
    • Drug: Ibuprofen
  • 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
    Interventions:
    • Drug: Placebo
    • Drug: Ibuprofen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
439
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01670656
P08257, 2012-002449-40, MK-8175A/MK-8342B-057
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP