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Phase 1/2 Study of Intravaginal Tamoxifen (DARE-VVA1): Randomized, Double-blind, Placebo-controlled Study of Safety, Pharmacokinetics and Pharmacodynamics in Postmenopausal Participants With Moderate to Sever Vulvar and Vaginal Atrophy

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Trial Profile

Phase 1/2 Study of Intravaginal Tamoxifen (DARE-VVA1): Randomized, Double-blind, Placebo-controlled Study of Safety, Pharmacokinetics and Pharmacodynamics in Postmenopausal Participants With Moderate to Sever Vulvar and Vaginal Atrophy

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 23 Oct 2024

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At a glance

  • Drugs Tamoxifen (Primary)
  • Indications Atrophic vaginitis
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Dare Bioscience

Most Recent Events

  • 21 Sep 2023 Results assessing safety, systemic pharmacokinetics and preliminary efficacy of a vaginal tamoxifen capsule among postmenopausal women with moderate-to-severe vulvovaginal atrophy published in the Climacteric
  • 20 Sep 2023 According to a Dare Bioscience media release, data from this study will be presented at the 2023 Annual Meeting of The Menopause Society (formerly known as The North American Menopause Society, or NAMS) taking place September 27-30, 2023 at the Marriott Downtown in Philadelphia, PA.
  • 17 Jul 2023 Status changed from active, no longer recruiting to completed.

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