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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
13
2.4 g in Vaginal Ring
3.0 g in Vaginal Ring
Instituto Chileno de Medicina Reproductiva (ICMER)
Santiago, Chile
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
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