US biopharma firm Daré Bioscience has started a Phase III trial investigating the effectiveness and safety of Ovaprene, a hormone-free intravaginal contraceptive.
The single-arm study aims to enrol approximately 250 participants at 20 sites across the US over 12 months, to have Ovaprene approved by the US Food and Drug Administration (FDA).
In July 2021, the company entered a Cooperative Research and Development Agreement (CRADA) with the US Department of Health and Human Services to collaborate on the Phase III trial. Under the agreement, Daré Bioscience received funding and access to the Eunice Kennedy Shriver National Institute of Child Health and Human Development’s (NICHD) clinical trial network.
Daré Bioscience president Sabrina Martucci Johnson said: “While we’ve seen improvements in hormonal contraception over the last 20 years, many women need more options and innovation in non-hormonal contraceptive methods.”
Ovaprene is a locally acting agent that impedes sperm motility as well as a knitted polymer barrier to physically block sperm from entering the cervical canal. It was previously demonstrated in a postcoital test clinical study (NCT03598088) which concluded in 2019.
In January 2020, Daré Bioscience entered a licensing agreement with Bayer. Under the agreement, the multinational pharmaceutical company has exclusive rights to market the product in the US following the completion of the new pivotal trial and drug approval.
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Research published by GlobalData found that the women’s healthcare market in the US was worth $147.3m in 2018, with that figure expected to grow to $153.2m by the end of 2025.
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Earlier this year, Daré Bioscience launched another clinical trial examining its DARE-PDM1, a method of delivering the nonsteroidal anti-inflammatory drug diclofenac vaginally to treat primary dysmenorrhea.
As recently reported by Clinical Trials Arena from the Pro-Manchester Health Tech Conference, experts highlighted the need for more data regarding women’s health conditions else the female health tech sector could be missing out on venture capital funding.