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Clinical Trials/ACTRN12619001163190
ACTRN12619001163190
Recruiting
Phase 3

Randomised, double-blind, placebo-controlled trial assessing the efficacy of Mi-Gel in the treatment of women with entry dyspareunia

Women's Health & Research Institute of Australia0 sites80 target enrollmentAugust 20, 2019
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Conditionsentry dyspareuniaRenal and Urogenital - Other renal and urogenital disordersNeurological - Other neurological disorders

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
entry dyspareunia
Sponsor
Women's Health & Research Institute of Australia
Enrollment
80
Status
Recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 20, 2019
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
Women's Health & Research Institute of Australia

Eligibility Criteria

Inclusion Criteria

  • •2\. Aged 18 or over
  • •3\. Entry dyspareunia duration of at least 3 months

Exclusion Criteria

  • •1\. Aged less than 18
  • •2\. Not sexually active
  • •3\. Current use of amitriptyline or oestriol (topical or oral)
  • •(Patients would be suitable for inclusion after a wash out period of six weeks)
  • •4\. Pudendal Nerve Block procedure within the last three months or planning on having a Pudendal Nerve Block procedure during the course of the trial
  • •5\. Known allergy to amitriptyline or oestriol
  • •6\. Contraindication to use of amitriptyline or oestriol
  • •7\. Pregnant or unwilling to use methods to avoid potential pregnancy, as determined by a urine test
  • •8\. Other peri\-vaginal infections or vulvovaginal disorders including current acute/chronic candidiasis or active DIV/psoriasis/lichen sclerosis
  • •9\. Endometrial hyperplasia or undiagnosed genital bleeding

Outcomes

Primary Outcomes

Not specified

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