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Multicenter, Double-blind, Randomized, Placebo-controlled Phase III Confirmatory Study of the Efficacy and Safety of BP101 in Female Patients With Decrease or Loss of Sexual Desire

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Trial Profile

Multicenter, Double-blind, Randomized, Placebo-controlled Phase III Confirmatory Study of the Efficacy and Safety of BP101 in Female Patients With Decrease or Loss of Sexual Desire

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Jan 2021

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At a glance

  • Drugs BP 101 (Primary)
  • Indications Decreased libido; Female sexual dysfunction
  • Focus Registrational; Therapeutic Use
  • Sponsors Ivix

Most Recent Events

  • 05 Jan 2021 According to an Ovoca Bio media release, upon confirming the submission, the Minzdrav will automatically commence a review process, which is expected to be a minimum of nine months duration.
  • 05 Jan 2021 According to an Ovoca Bio media release, based on the two Phase 1 studies, a Phase 2a study and the pivotal Phase 3 study, the company has resubmitted the Marketing Authorisation (MA) to the Russian Ministry of Health (Minzdrav) on 30 Dec 2020. The MA submission was not granted following the identification of issues relating to the chemistry, manufacturing and controls (CMC) and labelling sections of the MA submission dossier.
  • 10 Feb 2020 Status changed from recruiting to completed.

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