Assessment of a Vaginal Ring With Meloxicam on Ovarian Cycle in Fertile Women
Phase 1 Study of Assessment of Local Absorption of a Non-steroidal Antiinflammatory Drug (NSAID), Inhibitor of Cyclooxygenase 2 (COX-2) Meloxicam, Through a Vaginal Ring and Its Effect on Ovarian Cycle in Fertile Women
1 other identifier
interventional
13
1 country
1
Brief Summary
In this study, the investigators propose to assess if a non-hormonal agent is absorbed by a local route (vaginal) and to observe the effect on follicular development.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2013
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 15, 2013
CompletedFirst Submitted
Initial submission to the registry
March 18, 2013
CompletedFirst Posted
Study publicly available on registry
April 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 7, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 6, 2013
CompletedApril 30, 2019
April 1, 2019
4 months
March 18, 2013
April 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with follicular rupture delay
Evaluate effective dose of maximum local safety that causes a greater proportion of follicular rupture delays when it is administered continuously, starting on the day 5 +/- 1 of the cycle until next menses.
Participants will be followed for the duration of one menstrual cycle, an expected average of 28 days
Secondary Outcomes (4)
Pharmacokinetic of meloxicam via vaginal route: AUC
An expected average of 28 days
Bleeding patterns with meloxicam vaginal ring
one menstrual cycle
Pharmacokinetic of meloxicam via vaginal route: Tmax
An expected average of 28 days
Pharmacokinetic of meloxicam via vaginal route: Cmax
An expected average of 28 days
Study Arms (2)
2.4 g Meloxicam Vaginal Ring
EXPERIMENTALContinuous wearing during one menstrual cycle (6 participants)
3.0 g Meloxicam Vaginal Ring
EXPERIMENTALContinuous wearing during one menstrual cycle (6 participants)
Interventions
Eligibility Criteria
You may qualify if:
- Previous (or history of) proven fertility
- Regular menstrual cycle
- Surgically sterile
- Without breastfeeding
- Haemoglobin at least 11g/dL
- Willing to participate in the study
You may not qualify if:
- Allergy to meloxicam or other NSAID
- Allergy to silicone polymer
- Vaginal discharge non diagnosticated
- History of shock toxic syndrome
- History of : gastrointestinal, bleeding, renal, liver, heart, brain,clot, endocrine or pulmonary disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto Chileno de Medicina Reproductiva (ICMER)
Santiago, 8320165, Chile
Related Publications (1)
Jesam C, Salvatierra AM, Schwartz JL, Croxatto HB. Suppression of follicular rupture with meloxicam, a cyclooxygenase-2 inhibitor: potential for emergency contraception. Hum Reprod. 2010 Feb;25(2):368-73. doi: 10.1093/humrep/dep392. Epub 2009 Nov 19.
PMID: 19933235BACKGROUND
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Grünenthal Study Director
Grünenthal GmbH
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2013
First Posted
April 25, 2013
Study Start
January 15, 2013
Primary Completion
May 7, 2013
Study Completion
June 6, 2013
Last Updated
April 30, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share