Dysmenorrhea Clinical Trial
Official title:
Evaluation of the Effect of a Vaginal Ring With Meloxicam on Primary Dysmenorrhea in Women of Childbearing Age
Verified date | May 2019 |
Source | Laboratorios Andromaco S.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators propose that the sustained administration of a vaginal ring would have a
better response with respect to pain and a better safety profile than the oral administration
of a non-steroidal anti-inflammatory drug.
To assess the relief of the symptoms associated with dysmenorrhea, a specific survey was
elaborated that also includes a Visual Analog Scale (VAS) to objectify and measure
dysmenorrhea as is the case with McGill's Pain Questionnaire (MPQ).
Status | Completed |
Enrollment | 68 |
Est. completion date | March 16, 2016 |
Est. primary completion date | February 21, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Regular menstrual cycles on previous 3 months (24-35 days), - Primary dysmenorrhea on 3 previous months, - With tubal ligation or users of condom for contraception, - Hemoglobin of at least 11 g/dl, - Safety blood analysis in normal levels Exclusion Criteria: - Secondary dysmenorrhea, - Users of hormonal contraceptives (2 months prior to the study) or intrauterine devices (IUDs) (1 month prior the study). - Allergy to any anti-inflammatory drug including meloxicam or diclofenac. - Allergy to silicon. - Pregnant or in lactation. - Women with untreated or decompensated endocrine disorders |
Country | Name | City | State |
---|---|---|---|
Chile | Instituto Chileno de Medicina Reproductiva (ICMER) | Santiago |
Lead Sponsor | Collaborator |
---|---|
Laboratorios Andromaco S.A. |
Chile,
Chantler I, Mitchell D, Fuller A. The effect of three cyclo-oxygenase inhibitors on intensity of primary dysmenorrheic pain. Clin J Pain. 2008 Jan;24(1):39-44. doi: 10.1097/AJP.0b013e318156dafc. — View Citation
de Mello NR, Baracat EC, Tomaz G, Bedone AJ, Camargos A, Barbosa IC, de Souza RN, Rumi DO, Martinez Alcala FO, Velasco JA, Cortes RJ. Double-blind study to evaluate efficacy and safety of meloxicam 7.5 mg and 15 mg versus mefenamic acid 1500 mg in the treatment of primary dysmenorrhea. Acta Obstet Gynecol Scand. 2004 Jul;83(7):667-73. — View Citation
Harel Z. Cyclooxygenase-2 specific inhibitors in the treatment of dysmenorrhea. J Pediatr Adolesc Gynecol. 2004 Apr;17(2):75-9. Review. — View Citation
Marjoribanks J, Proctor M, Farquhar C, Derks RS. Nonsteroidal anti-inflammatory drugs for dysmenorrhoea. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD001751. doi: 10.1002/14651858.CD001751.pub2. Review. Update in: Cochrane Database Syst Rev. 2015;7:CD001751. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy: Percentage of primary dysmenorrhea reduction | Change in primary dysmenorrhea using the VAS (0 = pain-free, 10 = maximum pain intensity) for the vaginal ring with meloxicam used during the perimenstrual period compared with a placebo ring. | 5 months | |
Secondary | Minimum effective dose of meloxicam | Determine the minimum effective dose of the vaginal ring with meloxicam in primary dysmenorrhea using a survey. This survey includes a VAS (0 = pain-free, 10 = maximum pain intensity) to evaluate pain intensity, questions about the pain type (superficial, deep), pain location (diffuse, localized), pain duration (for a moment, intermittent, constant), location in the abdominal or back region (yes/no), and the presence of breast pain, thigh pain, mood changes, mastalgia, gastrointestinal disorders, abdominal distension, headache, dizziness, or acne (all with yes/no responses). Furthermore, the survey includes quality of life assessments (effects on routine activity, on work activity and/or housework, social and recreational activities, family and/or interpersonal relationships, state of mind, and sleep quality: 0 = no negative effect, 10 = maximum negative effect). | 5 months | |
Secondary | Efficacy: Comparison of meloxicam vaginal ring and oral diclofenac | Compare the effect of a vaginal ring with meloxicam versus the oral administration of a non-steroidal anti-inflammatory drug commonly used for primary dysmenorrhea during one menstrual cycle, using a survey. This survey includes a VAS (0 = pain-free, 10 = maximum pain intensity) to evaluate pain intensity, questions about the pain type (superficial, deep), pain location (diffuse, localized), pain duration (for a moment, intermittent, constant), location in the abdominal or back region (yes/no), and the presence of breast pain, thigh pain, mood changes, mastalgia, gastrointestinal disorders, abdominal distension, headache, dizziness, or acne (all with yes/no responses). Furthermore, the survey includes quality of life assessments (effects on routine activity, on work activity and/or housework, social and recreational activities, family and/or interpersonal relationships, state of mind, and sleep quality: 0 = no negative effect, 10 = maximum negative effect). | 5 months |
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 |