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

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.

Study Overview

• Status: Completed
• Conditions: Contraception; Bleeding Pattern
• Intervention / Treatment: Drug: Meloxicam 2.4 g; Drug: Meloxicam 3.0 g

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 1

Contacts and Locations

Study Locations

• Chile
  • Santiago, Chile, 8320165
    • Instituto Chileno de Medicina Reproductiva (ICMER)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2.4 g Meloxicam Vaginal Ring; Continuous wearing during one menstrual cycle (6 participants)	Drug: Meloxicam 2.4 g; 2.4 g in Vaginal Ring
Experimental: 3.0 g Meloxicam Vaginal Ring; Continuous wearing during one menstrual cycle (6 participants)	Drug: Meloxicam 3.0 g; 3.0 g in Vaginal Ring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic of meloxicam via vaginal route: AUC	The AUC of meloxicam serum levels	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.	one menstrual cycle
Pharmacokinetic of meloxicam via vaginal route: Tmax	Tmax of meloxicam serum levels	An expected average of 28 days
Pharmacokinetic of meloxicam via vaginal route: Cmax	Cmax of meloxicam serum levels	An expected average of 28 days

Collaborators and Investigators

• Sponsor: Laboratorios Andromaco S.A.
• Collaborators: Instituto Chileno de Medicina Reproductiva

Publications and helpful links

General Publications

• 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.

Helpful Links

• Link to clinical site

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2013
• Primary Completion (Actual): May 7, 2013
• Study Completion (Actual): June 6, 2013

Study Registration Dates

• First Submitted: March 18, 2013
• First Submitted That Met QC Criteria: April 22, 2013
• First Posted (Estimate): April 25, 2013

Study Record Updates

• Last Update Posted (Actual): April 30, 2019
• Last Update Submitted That Met QC Criteria: April 26, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: pharmacokinetic
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Meloxicam
• Other Study ID Numbers: AVM-01001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No