Clinical trial NCT01839643: Assessment of a Vaginal Ring With Meloxicam on Ovarian Cycle in Fertile Women
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Contraception
Bleeding Pattern
Keywords: pharmacokinetic
Lead sponsor: Laboratorios Andromaco S.A.
Sponsor class: INDUSTRY
Collaborators: name: Instituto Chileno de Medicina Reproductiva
First posted: 2013-04-25
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with follicular rupture delay
timeFrame: Participants will be followed for the duration of one menstrual cycle, an expected average of 28 days
Secondary outcomes:
measure: Pharmacokinetic of meloxicam via vaginal route: AUC
timeFrame: An expected average of 28 days
measure: Bleeding patterns with meloxicam vaginal ring
timeFrame: one menstrual cycle
measure: Pharmacokinetic of meloxicam via vaginal route: Tmax
timeFrame: An expected average of 28 days
measure: Pharmacokinetic of meloxicam via vaginal route: Cmax
timeFrame: An expected average of 28 days
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Instituto Chileno de Medicina Reproductiva (ICMER)
Study officials:
affiliation: Grünenthal GmbH
name: Grünenthal Study Director
role: STUDY_DIRECTOR
References:
citation: 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.