A Phase 1 interventional study of Meloxicam 2.4 g and Meloxicam 3.0 g in Contraception and Bleeding Pattern, sponsored by Laboratorios Andromaco S.A.. Completed at 1 site in Chile. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-30.
Sponsored by Laboratorios Andromaco S.A. · Phase 1, Interventional, and Diagnostic
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.
Each volunteer will participate for 3 menstrual cycles, beginning with one menstrual control cycle without treatment, following by one menstrual cycle with meloxicam ring administration, and finishing with another control menstrual cycle.
Meloxicam will be administered in the second menstrual cycle via a vaginal ring in two doses of 2.4 g or 3.0 g/ring. The safety of the vaginal ring and the absorption of meloxicam will be assessed. Also the effect on follicular development and if it maintains ovarian cyclicity, as shown in a recent study with oral administration, will be assessed.
Laboratorios Andromaco S.A. is the lead sponsor of 19 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Continuous wearing during one menstrual cycle (6 participants)
Drug: Meloxicam 2.4 g
Continuous wearing during one menstrual cycle (6 participants)
Drug: Meloxicam 3.0 g
2.4 g in Vaginal Ring
3.0 g in Vaginal Ring
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.
Time frame: Participants will be followed for the duration of one menstrual cycle, an expected average of 28 days
Pharmacokinetic of meloxicam via vaginal route: AUC
The AUC of meloxicam serum levels
Time frame: An expected average of 28 days
Bleeding patterns with meloxicam vaginal ring
Women will complete a menstrual diary during their participation to evaluate the effects of treatment on the menstrual pattern.
Time frame: one menstrual cycle
Pharmacokinetic of meloxicam via vaginal route: Tmax
Tmax of meloxicam serum levels
Time frame: An expected average of 28 days
Pharmacokinetic of meloxicam via vaginal route: Cmax
Cmax of meloxicam serum levels
Time frame: An expected average of 28 days
Plan to share: No
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Laboratorios Andromaco S.A.