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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01839643

Enrollment

Registered

2013-04-25

Start date

2013-01-15

Completion date

2013-06-06

Last updated

2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding Pattern, Contraception

Keywords

pharmacokinetic

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.

Detailed description

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.

Interventions

DRUGMeloxicam 2.4 g

2.4 g in Vaginal Ring

DRUGMeloxicam 3.0 g

3.0 g in Vaginal Ring

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* Previous (or history of) proven fertility * Regular menstrual cycle * Surgically sterile * Without breastfeeding * Haemoglobin at least 11g/dL * Willing to participate in the study

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with follicular rupture delay	Participants will be followed for the duration of one menstrual cycle, an expected average of 28 days	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.

Secondary

Measure	Time frame	Description
Pharmacokinetic of meloxicam via vaginal route: AUC	An expected average of 28 days	The AUC of meloxicam serum levels
Bleeding patterns with meloxicam vaginal ring	one menstrual cycle	Women will complete a menstrual diary during their participation to evaluate the effects of treatment on the menstrual pattern.
Pharmacokinetic of meloxicam via vaginal route: Tmax	An expected average of 28 days	Tmax of meloxicam serum levels
Pharmacokinetic of meloxicam via vaginal route: Cmax	An expected average of 28 days	Cmax of meloxicam serum levels

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026