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Last Updated: February 4, 2023

CLINICAL TRIALS PROFILE FOR INTRAROSA


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All Clinical Trials for Intrarosa

Trial ID Title Status Sponsor Phase Start Date Summary
NCT03568604 ↗ Changes to Vulva, Vestibule, Urethral Meatus and Vagina 20 Weeks Post Daily Prasterone in Women With Dyspareunia Unknown status San Diego Sexual Medicine Phase 4 2018-08-07 Open label study at a single research center. Subjects meeting inclusion and exclusion criteria will receive 6.5 mg prasterone vaginal inserts daily for twenty weeks. A physical examination and vulvoscopy with photography of the vulva, vestibule, urethral meatus and vagina will be performed at baseline and every 4 weeks for 20 weeks. Pain diaries will be completed between visits.
NCT03740945 ↗ Effect of Intravaginal Prasterone on Symptoms of VVA in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer Withdrawn AMAG Pharmaceuticals, Inc. Phase 3 2018-11-06 The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on moderate to severe (MS) and most bothersome symptoms (MBS) of vulvovaginal atrophy (VVA) due to natural, surgical or treatment-induced menopause, in women with breast cancer who are under treatment with an aromatase inhibitor.
NCT03740945 ↗ Effect of Intravaginal Prasterone on Symptoms of VVA in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer Withdrawn EndoCeutics Inc. Phase 3 2018-11-06 The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on moderate to severe (MS) and most bothersome symptoms (MBS) of vulvovaginal atrophy (VVA) due to natural, surgical or treatment-induced menopause, in women with breast cancer who are under treatment with an aromatase inhibitor.
NCT03782480 ↗ Examining Effects of Intrarosa in Women With Genitourinary Syndrome of Menopause/Vulvovaginal Atrophy Unknown status EndoCeutics Inc. Phase 3 2019-03-02 Tissues of the genitals of women are both androgen (testosterone) and estrogen dependent. The clitoris, vestibule, urethra, anterior vaginal wall, peri-urethral tissue, and pelvic floor all depend on androgens for normal function. In addition, the glands, which secrete lubrication during sexual arousal, also require androgens to function. Deficiencies of both estrogens and androgens occur naturally during menopause. Menopause-related deficiencies of these hormones lead to thinning in the tissues of the genital and urinary systems which have been termed Genitourinary Syndrome of Menopause (GSM). Patients with GSM will frequently complain of dryness and/or pain during sexual intercourse. Historically, GSM treatment involved both androgens and estrogens, However, over the past few decades estrogen based therapies have become much more common. More recently, clinical trials have demonstrated that local vaginal dehydroepiandrosterone (Intrarosa®) improves symptoms in menopausal women who have moderate to severe pain with intercourse. Intrarosa® vaginal inserts are a prescription medicine approved by the U.S. Food and Drug Administration (FDA) used in women after menopause to treat moderate to severe pain during sexual intercourse caused by changes in and around the vagina that happen with menopause.
NCT03782480 ↗ Examining Effects of Intrarosa in Women With Genitourinary Syndrome of Menopause/Vulvovaginal Atrophy Unknown status Center for Vulvovaginal Disorders Phase 3 2019-03-02 Tissues of the genitals of women are both androgen (testosterone) and estrogen dependent. The clitoris, vestibule, urethra, anterior vaginal wall, peri-urethral tissue, and pelvic floor all depend on androgens for normal function. In addition, the glands, which secrete lubrication during sexual arousal, also require androgens to function. Deficiencies of both estrogens and androgens occur naturally during menopause. Menopause-related deficiencies of these hormones lead to thinning in the tissues of the genital and urinary systems which have been termed Genitourinary Syndrome of Menopause (GSM). Patients with GSM will frequently complain of dryness and/or pain during sexual intercourse. Historically, GSM treatment involved both androgens and estrogens, However, over the past few decades estrogen based therapies have become much more common. More recently, clinical trials have demonstrated that local vaginal dehydroepiandrosterone (Intrarosa®) improves symptoms in menopausal women who have moderate to severe pain with intercourse. Intrarosa® vaginal inserts are a prescription medicine approved by the U.S. Food and Drug Administration (FDA) used in women after menopause to treat moderate to severe pain during sexual intercourse caused by changes in and around the vagina that happen with menopause.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Intrarosa

Condition Name

Condition Name for Intrarosa
Intervention Trials
Genitourinary Syndrome of Menopause 3
Postmenopausal Symptoms 2
Dyspareunia 2
Vulvovaginal Atrophy 2
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Condition MeSH

Condition MeSH for Intrarosa
Intervention Trials
Atrophy 6
Dyspareunia 3
Breast Neoplasms 3
Syndrome 2
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Clinical Trial Locations for Intrarosa

Trials by Country

Trials by Country for Intrarosa
Location Trials
United States 5
Spain 1
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Trials by US State

Trials by US State for Intrarosa
Location Trials
Arkansas 1
Kentucky 1
New York 1
District of Columbia 1
California 1
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Clinical Trial Progress for Intrarosa

Clinical Trial Phase

Clinical Trial Phase for Intrarosa
Clinical Trial Phase Trials
Phase 4 3
Phase 3 4
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Intrarosa
Clinical Trial Phase Trials
Recruiting 3
Unknown status 2
Withdrawn 2
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Clinical Trial Sponsors for Intrarosa

Sponsor Name

Sponsor Name for Intrarosa
Sponsor Trials
AMAG Pharmaceuticals, Inc. 3
EndoCeutics Inc. 2
San Diego Sexual Medicine 1
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Sponsor Type

Sponsor Type for Intrarosa
Sponsor Trials
Other 6
Industry 6
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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKesson
Johnson and Johnson
Mallinckrodt
Colorcon
Baxter

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