A Study to Evaluate the Effect of Vaginal Rings on Primary Dysmenorrhea (P08257/MK-8175A/MK-8342B-057)
This study is currently recruiting participants.
Verified April 2013 by Merck
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01670656
First received: August 14, 2012
Last updated: April 15, 2013
Last verified: April 2013
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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:
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 ]
| Estimated Enrollment: | 450 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 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:
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:
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:
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:
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01670656
Contacts
| Contact: Toll Free Number | 1-888-577-8839 |
Locations
| Australia | |
| Merck Sharp & Dohme | Recruiting |
| North Ryde, Australia | |
| Contact: Gary Jankelowitz 61 2 8988 8246 | |
| Belgium | |
| MSD Belgium BVBA/SPRL | Recruiting |
| Brussels, Belgium | |
| Contact: Danny D'Hulster 32 23734310 | |
| Chile | |
| Merck Sharp & Dohme (I.A.) Corp. | Recruiting |
| Santiago, Chile | |
| Contact: Maria Elena Azara Hernandez 56 2 6558958 | |
| Colombia | |
| MDS Colombia SAS | Recruiting |
| Bogota, Colombia | |
| Contact: Francesca Carvajal 57 1219109011090 | |
| Denmark | |
| Merck Sharp & Dohme | Recruiting |
| Glostrup, Denmark | |
| Contact: Gert Andersen 45 43287726 | |
| Germany | |
| Merck Sharp & Dohme GmbH | Recruiting |
| Haar, Germany | |
| Contact: Kristian Lobner 49 89 4561 1102 | |
| Mexico | |
| MSD | Recruiting |
| Mexico City, Mexico | |
| Contact: Jose Gregorio Quijada 555 481 9608 | |
| Netherlands | |
| Merck Sharp & Dohme BV | Recruiting |
| Haarlem, Netherlands | |
| Contact: Trea van der Galien 31-(0)23-5153153 | |
| New Zealand | |
| Merck Sharp & Dohme (New Zealand) Ltd., | Recruiting |
| Wellington, New Zealand | |
| Contact: Gary Jankelowitz 61 2 8988 8246 | |
| Norway | |
| MSD Norge A/S | Recruiting |
| Drammen, Norway | |
| Contact: Jon Sigurd Riis 47 32207465 | |
| Poland | |
| MSD Polska Sp. Z o.o. | Recruiting |
| Warsaw, Poland | |
| Contact: Adam Czernik 48 22 4784324 | |
| South Africa | |
| MSD (Pty) LTD South Africa | Recruiting |
| Midrand, South Africa | |
| Contact: Vikram Singh 27 116553290 | |
| Spain | |
| Merck Sharp and Dohme de Espana S.A. | Recruiting |
| Madrid, Spain | |
| Contact: Cesar Sanz Rodriguez 34 913210600 | |
| Sweden | |
| MSD | Recruiting |
| Sollentuna, Sweden | |
| Contact: Tryggve Ljung 46 (0)70 545 28 66 | |
Sponsors and Collaborators
Merck
More Information
No publications provided
| Responsible Party: | Merck |
| 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: | April 15, 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 Contraceptive Agents 3-keto-desogestrel Megestrol Ibuprofen Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents Contraceptive Agents, Female Antineoplastic Agents, Hormonal Antineoplastic Agents Contraceptives, Oral, Synthetic Contraceptives, Oral |
ClinicalTrials.gov processed this record on June 17, 2013