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Safety, and acceptability of a non-hormonal vaginal ring

Award Number: R44HD095724
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/11/2019
PERIOD OF PERFORMANCE END DATE: 02/28/2021

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Safety, and acceptability of a non-hormonal vaginal ring - Modern contraceptives not only play a critical role in preventing unplanned pregnancy but also contribute to a woman’s well-being by empowering her with the necessary resources to control her own reproductive health. However, currently available female contraceptives are lacking in one or more important parameters, including effectiveness, safety, and usability, thus rendering the currently available contraceptive mix sub-optimal. A high impact driver of the growing contraceptives market is the number of unintended pregnancies, the risk of which is increased when contraceptives are used incorrectly, inconsistently, or not at all. Approximately 1.9 million unintended pregnancies were reported in the US in 2016, posing a significant medical risk for mothers and children, and placing significant economic burdens on individual women and the general public. Imperfect use of currently available contraceptive options can be attributed to a range of obstacles, including inconvenience (daily action, or action at the time of intercourse) and adverse side effects associated with hormonal contraceptives. These drawbacks demonstrate a need for novel, non-hormonal contraceptive options that are convenient, easy-to-use, and effective. To meet this need, Daré Bioscience, Inc. is developing the Ovaprene® device, a non-hormonal intravaginal ring that provides a safe and effective monthly birth control option. Ovaprene combines a flexible mesh barrier that covers the cervix while slowly releasing a mix of non-hormonal, spermiostatic ingredients. The FDA has already designated Ovaprene as a combination product and determined that the Center for Devices and Radiological Health (CDRH) will be the lead reviewing agency for this novel contraceptive. The objective of this SBIR proposal is to demonstrate the preliminary contraceptive performance, safety, active agent release profile, acceptance, and fit of Ovaprene in a single-center, open-label, non-significant risk device study. Preliminary efficacy will be evaluated by postcoital testing and the measurement of any progressively motile sperm gaining access to the cervix in women wearing the Ovaprene device. Safety will be evaluated over 28 days of continuous use. We will also establish post-production quality control metrics and collect agent release data. The successful accomplishment of all milestones in this proposal will provide necessary information to support a Pivotal efficacy human study of Ovaprene contraceptive effectiveness in advance of FDA clearance for the US market.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	DARE BIOSCIENCE, INC.	3655 NOBEL DR STE 260	SAN DIEGO	CA	92122	SAN DIEGO	USA	Child Health and Human Development Extramural Research	000	3	8/13/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $730,722 )
2020	2020	DARE BIOSCIENCE, INC.	3655 NOBEL DR STE 260	SAN DIEGO	CA	92122	SAN DIEGO	USA	Child Health and Human Development Extramural Research	000	3	3/30/2020	NON-COMPETING CONTINUATION	$730,722
														Subtotal = $730,722

Issue Date FY: 2019 ( Subtotal = $982,851 )
2019	2019	DARE BIOSCIENCE, INC.	3655 NOBEL DR STE 260	SAN DIEGO	CA	92122	SAN DIEGO	USA	Child Health and Human Development Extramural Research	001	2	3/6/2019	EXTENSION WITH OR WITHOUT FUNDS	$982,851
2019	2018	DARE BIOSCIENCE INC	3216 CAMINITO EASTBLUFF UNIT 67	LA JOLLA	CA	92037	SAN DIEGO	USA	Child Health and Human Development Extramural Research	000	1	2/1/2019	NEW	$0
														Subtotal = $982,851

Issue Date FY: 2018 ( Subtotal = $224,655 )
2018	2018	DARE BIOSCIENCE INC	3216 CAMINITO EASTBLUFF UNIT 67	LA JOLLA	CA	92037	SAN DIEGO	USA	Child Health and Human Development Extramural Research	000	1	4/27/2018	NEW	$224,655
														Subtotal = $224,655

Grand Total All Awards = $1,938,228

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Safety, and acceptability of a non-hormonal vaginal ring

Award Number: R44HD095724

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 03/11/2019

PERIOD OF PERFORMANCE END DATE: 02/28/2021

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