{"id":961405,"date":"2026-05-12T09:11:43","date_gmt":"2026-05-12T13:11:43","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/positive-interim-phase-3-results-highlight-potential-of-ovaprene-novel-hormone-free-contraceptive-2\/"},"modified":"2026-05-12T09:11:43","modified_gmt":"2026-05-12T13:11:43","slug":"positive-interim-phase-3-results-highlight-potential-of-ovaprene-novel-hormone-free-contraceptive-2","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/positive-interim-phase-3-results-highlight-potential-of-ovaprene-novel-hormone-free-contraceptive-2\/","title":{"rendered":"Positive Interim Phase 3 Results Highlight Potential of Ovaprene\u00ae, Novel Hormone-Free Contraceptive"},"content":{"rendered":"
\n

\n Second Positive DSMB Review Supports Continued Study Progress<\/strong>\n <\/p>\n

\n Interim Phase 3 Results Support Ovaprene\u2019s Differentiation as a First-in-Category, Hormone-Free, Intravaginal Monthly Contraceptive<\/strong>\n <\/p>\n

SAN DIEGO, May 12, 2026 (GLOBE NEWSWIRE) — Dar\u00e9 Bioscience, Inc. (NASDAQ: DARE),<\/strong> a purpose-driven health biotech company solely focused on closing the gap in women\u2019s health between promising science and real-world solutions, today announced positive interim safety and efficacy results from its ongoing Phase 3 clinical trial evaluating the contraceptive effectiveness, safety and acceptability of Ovaprene\u00ae, the company\u2019s investigational monthly, hormone-free intravaginal contraceptive. There currently are no FDA-approved, hormone-free, monthly intravaginal contraceptives.<\/p>\n

The trial\u2019s independent Data Safety Monitoring Board (DSMB) conducted a planned interim analysis focused on reviewing safety data from the study, and recommended the study continue without modification.<\/p>\n

The DSMB\u2019s findings and recommendation to continue the study are consistent with those from its prior interim analysis conducted in July 2025.<\/p>\n

As was the case with the data presented to the DSMB in July 2025, these interim data show that approximately 9% of the women treated in the study had experienced a pregnancy, a rate consistent with the company\u2019s expectations based on the results of the pre-pivotal postcoital test\u00a0clinical study<\/a>\u00a0of Ovaprene. These findings reinforce Ovaprene\u2019s potential as a meaningful hormone-free contraceptive alternative.<\/p>\n

No new types of adverse events or tolerability concerns were identified. Neither an increase in the frequency of adverse events nor the emergence of new types of adverse events was observed with prolonged Ovaprene use. Approximately 12% of participants discontinued the study due to vaginal odor, the most commonly reported product-related adverse event \u2013 a 5% decrease compared to data reviewed by the DSMB in July 2025. No serious adverse events related to the study device were identified. A majority of participants who had completed the study reported they would be very likely or likely to use Ovaprene if it became available.<\/p>\n

\u201cWe are encouraged by these interim results and this second positive DSMB review,\u201d said Sabrina Martucci Johnson, President and CEO of Dar\u00e9 Bioscience. \u201cMillions of women in the U.S. are seeking effective, hormone-free birth control, and Ovaprene has the potential to address a significant unmet need and transform the contraceptive landscape. We look forward to advancing toward the primary endpoint analysis as we complete the study.\u201d<\/p>\n

According to the FDA\u2019s birth control guide<\/a>, the number of pregnancies expected using short-acting hormonal contraceptive methods\u2014including oral contraceptives (\u201cthe pill\u201d), the patch (transdermal system), and the vaginal ring\u2014is seven per 100 women, and the number of pregnancies expected using male condoms is 13 per 100 women, and 17 per 100 women using diaphragms or sponges with spermicide.<\/p>\n

For the interim analysis, the DSMB reviewed data from 339 study subjects, contributing 1,789 menstrual cycles of safety data, representing a meaningful proportion of the study\u2019s 2,500-cycle target. The ongoing pivotal Phase 3 trial is a multicenter, single-arm, open-label study enrolling women aged 18\u201340 across five sites. The study protocol calls for at least 2,500 cycles of exposure and at least 250 subjects completing 13 menstrual cycles of use. Based on current enrollment trends, the Company expects to achieve 2,500 cycles of exposure before 250 subjects complete 13 menstrual cycles of use. Interim safety data reviewed by the DSMB indicate that prolonged product use was not associated with the emergence of new types of adverse events or an increase in the frequency of adverse events, which the Company believes may support the sufficiency of fewer than 250 subjects completing 13 menstrual cycles of use to evaluate Ovaprene’s safety profile. The Company intends to engage with FDA regarding these findings. The Company currently expects to complete enrollment sufficient to achieve at least 2,500 cycles of exposure in 2026. The primary objective of the study is to assess the typical-use pregnancy rate over 13 menstrual cycles, expressed as the\u00a0Pearl Index<\/a>, a standard measure of contraceptive effectiveness. Secondary objectives include assessment of Ovaprene\u2019s 13-cycle cumulative pregnancy rate, safety, acceptability, product fit\/ease of use, and vaginal health. For more information about the study, please visit clinicaltrials.gov (ID # NCT06127199).<\/p>\n

\n About Dar\u00e9 Bioscience<\/strong>\n <\/p>\n

Dar\u00e9 Bioscience is a purpose-driven health biotech company solely focused on closing the gap in women\u2019s health between promising science and real-world solutions. Every innovation Dar\u00e9 advances is based in advanced science and backed by rigorous, peer-reviewed research. From contraception to menopause, pelvic pain to fertility, vaginal health to infectious disease, Dar\u00e9 is working to close critical gaps in care using science that serves her needs.<\/p>\n

For decades, women have been told to \u201cwait it out\u201d or \u201clive with it,\u201d while innovations that could improve their quality of life languish in the regulatory or funding pipeline. With growing awareness around menopause, sexual health, and vaginal health, the conversation is shifting. However, access to real, evidence-based solutions continues to lag. Dar\u00e9 was founded to change that. As a female-led health biotech company, Dar\u00e9 is accelerating the development of credible, science-based solutions that meet the high standards of clinical rigor \u2013 randomized, controlled trials; validated endpoints; peer-reviewed publications; and current Good Manufacturing Practice (cGMP) requirements.<\/p>\n

To learn more about Dar\u00e9\u2019s mission to deliver differentiated therapies for women and its innovation pipeline, please visit www.darebioscience.com<\/a>.<\/p>\n

Dar\u00e9 Bioscience leadership has been named on the Medicine Maker\u2019s Power List and Endpoints News\u2019 Women in Biopharma and Dar\u00e9\u2019s CEO has been honored as one of Fierce Pharma\u2019s Most Influential People in Biopharma for Dar\u00e9\u2019s contributions to innovation and advocacy in the women\u2019s health space.<\/p>\n

Dar\u00e9 may announce material information about its finances, products and product candidates, clinical trials and other matters using the Investors section of its website (http:\/\/ir.darebioscience.com<\/a>), SEC filings, press releases, public conference calls and webcasts, and social media channels. The information Dar\u00e9 posts on its investor relations website or through social media channels may be deemed to be material information. Dar\u00e9 encourages investors, the media, and others interested in the company to review the information Dar\u00e9 posts in the Investors section of its website, to follow Dar\u00e9 Bioscience, Inc. on LinkedIn, and to follow these X (formerly Twitter) accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the list of social media channels the company may use to communicate information will be posted in the Investors section of Dar\u00e9\u2019s website.<\/p>\n

\n Forward-Looking Statements<\/strong>\n <\/p>\n

Dar\u00e9 cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as \u201cbelieve,\u201d \u201cmay,\u201d \u201cwill,\u201d \u201cestimate,\u201d \u201ccontinue,\u201d \u201canticipate,\u201d \u201cdesign,\u201d \u201cintend,\u201d \u201cexpect,\u201d \u201ccould,\u201d \u201cplan,\u201d \u201cpotential,\u201d \u201cprepare,\u201d \u201cseek,\u201d \u201cshould,\u201d \u201cwould,\u201d \u201ctarget,\u201d \u201cobjective,\u201d \u201cpositioned,\u201d or the negative version of these words and similar expressions.\u00a0 In this press release, forward-looking statements include, but are not limited to, statements relating to Ovaprene\u2019s potential as a safe and effective first-in-category, hormone-free, intravaginal monthly contraceptive, Ovaprene\u2019s potential to be the first U.S. Food and Drug Administration (FDA)-approved hormone-free, monthly intravaginal contraceptive, the importance of the interim results from the ongoing pivotal Phase 3 study of Ovaprene to Dar\u00e9 and Ovaprene, that enrollment in the study will be completed in 2026, that fewer than 250 subjects completing 13 menstrual cycles of use may support an evaluation of Ovaprene\u2019s safety profile, Dar\u00e9\u2019s intention to engage with FDA regarding the study protocol, the anticipated timing of the primary endpoint analysis, and Ovaprene\u2019s potential, if approved, to address an unmet medical need in hormone-free contraception. As used in this press release, \u201cfirst-in-category\u201d is a forward-looking statement relating to the potential of a product candidate to represent a new category of product if it were to receive marketing approval for the indication for which it is being developed because Dar\u00e9 believes it would address a need in women\u2019s health that is not being met by existing FDA-approved products. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Dar\u00e9\u2019s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, without limitation, risks and uncertainties related to: the risk that positive findings in early clinical and\/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and\/or nonclinical studies of that candidate; Dar\u00e9\u2019s ability to develop, obtain FDA or foreign regulatory approval for, and commercialize its product candidates and to do so on communicated timelines; failure or delay in starting, completing or conducting clinical trials of a product candidate and the inherent uncertainty of outcomes of clinical trials; the potential that a product candidate in clinical development may never advance into or through a pivotal clinical study or obtain FDA or foreign regulatory approval; the risk that Dar\u00e9\u2019s product candidates may fail to demonstrate acceptable safety and tolerability or sufficient efficacy in clinical trials; Dar\u00e9\u2019s ability to design and conduct successful clinical trials, to enroll a sufficient number of patients, to meet established clinical endpoints, to avoid undesirable side effects and other safety concerns, and to demonstrate sufficient safety and efficacy of its product candidates; Dar\u00e9\u2019s dependence on third parties to conduct clinical trials and manufacture and supply clinical trial material and commercial product; the risk that the FDA, other regulatory authorities, members of the scientific or medical communities or investors may not accept or agree with Dar\u00e9\u2019s interpretation of or conclusions regarding data from clinical studies of its product candidates, including that fewer than 250 subjects completing 13 menstrual cycles of use is sufficient to support an evaluation of Ovaprene\u2019s safety profile; the risk that development of a product candidate requires more clinical or nonclinical studies than Dar\u00e9 anticipates, or that the duration of a study or number of study subjects must be significantly greater than anticipated; Dar\u00e9\u2019s ability to raise additional capital when and as needed to execute its business strategy and continue as a going concern; Dar\u00e9\u2019s dependence on grants and other financial awards from governmental entities and a private foundation; Dar\u00e9\u2019s ability to maintain compliance with Nasdaq\u2019s continued listing requirements and continue to have its common stock listed on The Nasdaq Capital Market; the effects of macroeconomic conditions, geopolitical events, and major changes and disruptions in U.S. government policies and operations on Dar\u00e9\u2019s ability to raise additional capital or on Dar\u00e9\u2019s operations, financial results and condition, and ability to achieve current plans and objectives; the risk that the current regulatory pathway known as the FDA\u2019s 505(b)(2) pathway for drug product approval in the U.S. is not available for a product candidate as Dar\u00e9 anticipates; the risk that developments by competitors make Dar\u00e9\u2019s product or product candidates less competitive or obsolete; difficulties establishing and sustaining relationships with development and\/or commercial collaborators; failure of Dar\u00e9\u2019s product or product candidates, if approved, to gain market acceptance or obtain adequate coverage, pricing and reimbursement from third-party payors; Dar\u00e9\u2019s ability to retain its licensed rights to develop and commercialize a product or product candidate; Dar\u00e9\u2019s ability to satisfy the monetary obligations and other requirements in connection with its exclusive, in-license agreements covering the critical patents and related intellectual property related to its product and product candidates; Dar\u00e9\u2019s ability to adequately protect or enforce its, or its licensor\u2019s, intellectual property rights; the lack of patent protection for the active ingredients in certain of Dar\u00e9\u2019s product candidates which could expose its products to competition from other formulations using the same active ingredients; product liability claims; governmental investigations or actions relating to Dar\u00e9\u2019s products or product candidates or the business activities of Dar\u00e9, its commercial collaborators or other third parties on which Dar\u00e9 relies; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; and cybersecurity incidents or similar events that compromise Dar\u00e9\u2019s technology systems and\/or significantly disrupt Dar\u00e9\u2019s business or those of third parties on which Dar\u00e9 relies. Dar\u00e9\u2019s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of Dar\u00e9\u2019s risks and uncertainties, you are encouraged to review its documents filed with the U.S. Securities and Exchange Commission, or SEC, including Dar\u00e9\u2019s recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Dar\u00e9 undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.<\/p>\n

\n Contacts:<\/strong>\n <\/p>\n

\n Dar\u00e9 Bioscience Investor Relations<\/strong>\n <\/p>\n

innovations@darebioscience.com
Source: Dar\u00e9 Bioscience, Inc.<\/p>\n

\"\"
\n
\n \"\"\n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

Second Positive DSMB Review Supports Continued Study Progress Interim Phase 3 Results Support Ovaprene\u2019s Differentiation as a First-in-Category, Hormone-Free, Intravaginal Monthly Contraceptive SAN DIEGO, May 12, 2026 (GLOBE NEWSWIRE) — Dar\u00e9 Bioscience, Inc. (NASDAQ: DARE), a purpose-driven health biotech company solely focused on closing the gap in women\u2019s health between promising science and real-world solutions, today announced positive interim safety and efficacy results from its ongoing Phase 3 clinical trial evaluating the contraceptive effectiveness, safety and acceptability of Ovaprene\u00ae, the company\u2019s investigational monthly, hormone-free intravaginal contraceptive. There currently are no FDA-approved, hormone-free, monthly intravaginal contraceptives. The trial\u2019s independent Data Safety Monitoring Board (DSMB) conducted a planned interim analysis focused on reviewing safety data from the study, and recommended the study … <\/p>\n

Continue reading “Positive Interim Phase 3 Results Highlight Potential of Ovaprene\u00ae, Novel Hormone-Free Contraceptive”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-961405","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nPositive Interim Phase 3 Results Highlight Potential of Ovaprene\u00ae, Novel Hormone-Free Contraceptive - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/positive-interim-phase-3-results-highlight-potential-of-ovaprene-novel-hormone-free-contraceptive-2\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Positive Interim Phase 3 Results Highlight Potential of Ovaprene\u00ae, Novel Hormone-Free Contraceptive - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Second Positive DSMB Review Supports Continued Study Progress Interim Phase 3 Results Support Ovaprene\u2019s Differentiation as a First-in-Category, Hormone-Free, Intravaginal Monthly Contraceptive SAN DIEGO, May 12, 2026 (GLOBE NEWSWIRE) — Dar\u00e9 Bioscience, Inc. (NASDAQ: DARE), a purpose-driven health biotech company solely focused on closing the gap in women\u2019s health between promising science and real-world solutions, today announced positive interim safety and efficacy results from its ongoing Phase 3 clinical trial evaluating the contraceptive effectiveness, safety and acceptability of Ovaprene\u00ae, the company\u2019s investigational monthly, hormone-free intravaginal contraceptive. There currently are no FDA-approved, hormone-free, monthly intravaginal contraceptives. 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/positive-interim-phase-3-results-highlight-potential-of-ovaprene-novel-hormone-free-contraceptive-2\/","og_locale":"en_US","og_type":"article","og_title":"Positive Interim Phase 3 Results Highlight Potential of Ovaprene\u00ae, Novel Hormone-Free Contraceptive - Market Newsdesk","og_description":"Second Positive DSMB Review Supports Continued Study Progress Interim Phase 3 Results Support Ovaprene\u2019s Differentiation as a First-in-Category, Hormone-Free, Intravaginal Monthly Contraceptive SAN DIEGO, May 12, 2026 (GLOBE NEWSWIRE) — Dar\u00e9 Bioscience, Inc. (NASDAQ: DARE), a purpose-driven health biotech company solely focused on closing the gap in women\u2019s health between promising science and real-world solutions, today announced positive interim safety and efficacy results from its ongoing Phase 3 clinical trial evaluating the contraceptive effectiveness, safety and acceptability of Ovaprene\u00ae, the company\u2019s investigational monthly, hormone-free intravaginal contraceptive. There currently are no FDA-approved, hormone-free, monthly intravaginal contraceptives. The trial\u2019s independent Data Safety Monitoring Board (DSMB) conducted a planned interim analysis focused on reviewing safety data from the study, and recommended the study … Continue reading \"Positive Interim Phase 3 Results Highlight Potential of Ovaprene\u00ae, Novel Hormone-Free Contraceptive\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/positive-interim-phase-3-results-highlight-potential-of-ovaprene-novel-hormone-free-contraceptive-2\/","og_site_name":"Market Newsdesk","article_published_time":"2026-05-12T13:11:43+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTcxODE0NyM3NTk3MjYyIzIwMDgzNjQ=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"11 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/positive-interim-phase-3-results-highlight-potential-of-ovaprene-novel-hormone-free-contraceptive-2\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/positive-interim-phase-3-results-highlight-potential-of-ovaprene-novel-hormone-free-contraceptive-2\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Positive Interim Phase 3 Results Highlight Potential of Ovaprene\u00ae, Novel Hormone-Free Contraceptive","datePublished":"2026-05-12T13:11:43+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/positive-interim-phase-3-results-highlight-potential-of-ovaprene-novel-hormone-free-contraceptive-2\/"},"wordCount":2130,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/positive-interim-phase-3-results-highlight-potential-of-ovaprene-novel-hormone-free-contraceptive-2\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTcxODE0NyM3NTk3MjYyIzIwMDgzNjQ=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/positive-interim-phase-3-results-highlight-potential-of-ovaprene-novel-hormone-free-contraceptive-2\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/positive-interim-phase-3-results-highlight-potential-of-ovaprene-novel-hormone-free-contraceptive-2\/","name":"Positive Interim Phase 3 Results Highlight Potential of Ovaprene\u00ae, Novel Hormone-Free Contraceptive - 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