Dysmenorrhea Clinical Trial
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)
Verified date | February 2022 |
Source | Organon and Co |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 439 |
Est. completion date | September 12, 2013 |
Est. primary completion date | September 11, 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Organon and Co |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change From Baseline in Total Mean Impact Score Through Cycle 2 | Total Mean Impact Score is the mean of the sum of the daily responses to questions 6, 8, 9, and 10 in the Dysmenorrhea Daily e-Dairy, as recorded within the menstrual cramping pain analysis window. These questions assessed how much interference there was from pelvic cramping pain on work/school activities (Q6), physical activities (Q8), social/leisure activities (Q9) and sleep (Q10). Each question was rated on a 5-point (0-4) scale, with 0 being "not at all", 1 "slightly", 2 "moderately", 3 "quite a bit" and 4 "extremely". The total mean impact score could thus range from 0 (lowest possible impact) to 16 (highest possible impact). | Baseline and Day 29 to 56 (Cycle 2) | |
Secondary | Change From Baseline in Number of Ibuprofen Tablets Taken Through Cycle 2 | Participants were provided with ibuprofen 400 mg tablets at the screening visit to be taken throughout the study as needed as rescue medication for treating menstrual cramping pain. The maximum daily ibuprofen dose was 3200 mg (8 tablets). Participants were instructed to take the provided ibuprofen, and no other medications, for the relief of menstrual cramping pain, and to record their ibuprofen usage in their e-Diaries. | Baseline and Day 29 to 56 (Cycle 2) | |
Secondary | Change From Baseline in Number of Days of Ibuprofen Intake Through Cycle 2 | Participants were provided with ibuprofen 400 mg tablets at the screening visit to be taken throughout the study as needed as rescue medication for treating menstrual cramping pain. The maximum daily ibuprofen dose was 3200 mg (8 tablets). Participants were instructed to take the provided ibuprofen, and no other medications, for the relief of menstrual cramping pain, and to record their ibuprofen usage in their e-Diaries. | Baseline and Day 29 to 56 (Cycle 2) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04607382 -
Survey on Menstrual Symptoms, Health Related Quality of Life and Work Productivity in Patients Suffering From Pain During Menstruation (Dysmenorrhea) in Japan
|
||
Recruiting |
NCT04091789 -
Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea
|
Phase 2 | |
Completed |
NCT00769964 -
VA111913 TS: First in Human Study
|
Phase 1 | |
Completed |
NCT00746096 -
Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Primary Dysmenorrhea
|
Phase 3 | |
Completed |
NCT00104546 -
Vitamin K Injections for the Treatment of Painful Menstruation
|
Phase 1 | |
Completed |
NCT06011928 -
MOPEXE and RE in Treating Dysmenorrhea
|
N/A | |
Not yet recruiting |
NCT06398990 -
The Effect of Cognitive Exercise Therapy Approach and Yoga in Adolescents With Dysmenorrhoea
|
N/A | |
Recruiting |
NCT02031523 -
Multi-center Clinical Trials of Sanjie Analgesic Capsule in Treating Endometriosis
|
Phase 4 | |
Completed |
NCT01449305 -
Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea
|
N/A | |
Completed |
NCT00995917 -
A Pilot Study of Acupoint Injection for Primary Dysmenorrhea
|
N/A | |
Completed |
NCT02910167 -
Observational Prospective Study to Evaluate AEs, Risk Factors and Drug Utilization of BUSCAPINA COMPOSITUM N in Adults From Metropolitan Lima
|
||
Not yet recruiting |
NCT05461846 -
Effect of Integrated Neuromuscular Inhibition Technique in Females With Menstrual Low Back Pain
|
N/A | |
Completed |
NCT05247333 -
Implementation of a Minor Ailment Service in Community Pharmacy Practice
|
N/A | |
Not yet recruiting |
NCT03697746 -
Comparison of Dexketoprofen, Paracetamol and Ibuprofen in the Treatment of Primary Dysmenorrhea
|
N/A | |
Recruiting |
NCT03394547 -
Pulsed Electromagnetic Field Treatment for Painful Periods
|
N/A | |
Recruiting |
NCT06294743 -
Posterior Tibia Nerve Neuroprolotherapy for Dysmenorrhea
|
Early Phase 1 | |
Active, not recruiting |
NCT01738204 -
The Women's Health Study: From Adolescence to Adulthood
|
||
Completed |
NCT01462370 -
Study to Assess the Safety and Efficacy of Etoricoxib Versus Ibuprofen in the Treatment of Dysmenorrhea (MK-0663-145 AM1)
|
Phase 3 | |
Completed |
NCT01250587 -
Dose-Finding Study of PDC31 in Patients With Primary Dysmenorrhea
|
Phase 1 | |
Completed |
NCT00951561 -
A Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen
|
N/A |