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NCT02255045
Assessment of a Vaginal Ring With Meloxicam in the Treatment of Dysmenorrhea
Phase 2, PHASE3 trial testing Meloxicam in Dysmenorrhea in 68 participants. Completed in 16 March 2016.
21 February 2016
Quick facts
| Lead sponsor | Laboratorios Andromaco S.A. |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 68 |
| Start date | 27 June 2014 |
| Primary completion | 21 February 2016 |
| Estimated completion | 16 March 2016 |
| Sites | 1 location across Chile |
Drugs / interventions tested
- Meloxicam (MELOXICAM) — full drug profile →
- Diclofenac Potassium — full drug profile →
- Placebo Oral
- Placebo Vaginal
Conditions studied
- Dysmenorrhea — all drugs for Dysmenorrhea →
Sponsor
Laboratorios Andromaco S.A. — full company profile →
Who can join
Adults 18 to 45, female only, with Dysmenorrhea. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02255045
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Dysmenorrhea
Currently open trials in the same condition.
- NCT07209566 — A Research Study Exploring How Musculoskeletal Function and the Autonomic Nervous System Relate to Visceral Pain in Wome · NA · recruiting
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- NCT07036913 — Effectiveness of ST With TENS and Stretching Exercises on Menstrual Pain and QOL With Dysmenorrhea. RCT · NA · active not recruiting
- NCT07081789 — Music and Puzzle Use in Dysmenorrhea Relief · NA · active not recruiting
- NCT06741059 — Effect of TENS on Pain and Symptoms in Primary Dysmenorrhea · NA · recruiting
Other Laboratorios Andromaco S.A. trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02255045 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Laboratorios Andromaco S.A.
- Last refreshed: 3 May 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02255045.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing