Trial Profile
Sinecatechins Ointment, a Botanical Drug Derived From Green Tea, for the Treatment of Significant to Severe Secondary Provoked Vestibulodynia in Sexually Active, Post-Menopausal Women With Vulvovaginal Atrophy
Status:
Discontinued
Phase of Trial:
Phase II
Latest Information Update: 30 Jun 2022
Price :
$35
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At a glance
- Drugs Polyphenon E (Primary)
- Indications Vulvodynia
- Focus Therapeutic Use
- Sponsors GTO Pharmaceuticals
- 05 Oct 2021 Number of arms changed from 2 to 3. Active Comparator: 5% Topical sinecatechins ointment added to study protocol. Timeframe changed to Change in the Numerical Rating Scale for pain will be assessed weekly for 4 weeks including one week after completing use of the study ointment.
- 05 Oct 2021 Status changed from recruiting to discontinued due to pandemic.
- 19 May 2020 The trial protocol eligibility criteria was amended to include women taking estrogens in the trial, as reported by ClinicalTrials.gov record.