Menopause Clinical Trial
Official title:
A Placebo-controlled Study Examining the Morphological/Biochemical Effects of Intrarosa on the Vulvar Vestibule and Vagina in Women With Genitourinary Syndrome of Menopause/Vulvovaginal Atrophy
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | January 2, 2021 |
Est. primary completion date | January 2, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Postmenopausal women aged 40 to 80 years. 2. Women who have self-identified at screening pain at sexual activity as moderate to severe and most bothersome symptom of vulvovaginal atrophy (Refer to Vaginal Atrophy Symptoms Questionnaire (VASQ-MBS)). 3. Women having =5% of superficial cells on vaginal smear at screening. 4. Women having a vaginal pH above 5 at screening. 5. Willing to participate in the study and sign an informed consent. Exclusion Criteria: 1. Clinically significant metabolic or endocrine disease (including diabetes mellitus) not controlled by medication. 2. Use of estrogen injectable drug therapy and/or progestin implant within 6 months prior to screening visit. 3. Oral estrogen, progestin or DHEA exposure or intrauterine progestin therapy within 8 weeks prior to screening visit. 4. Vaginal hormonal products (rings, creams, gels or tablets) or transdermal estrogen alone or estrogen/progestin products within 8 weeks prior to screening visit. 5. Previous treatment with androgens or anabolic steroids within 3 months prior to screening visit (see Appendix 15.1 - Concomitant medications). 6. Confirmed clinically significant depression (not controlled by standard therapy) or confirmed history of severe psychiatric disturbance. 7. The administration of any investigational drug within 30 days of screening visit. 8. Clinically significant abnormal serum biochemistry, urinalysis or hematology (as per Investigator's assessment who should take into account the patient's pre-baseline conditions). 9. Uterine palpable fibroids. 10. Uterine prolapse (when the cervix reaches labia minora at gynecologic exam). 11. Subjects who suffer from vulvar lichen sclerosus or any vulvar dermatological disorder that affects the vulvar vestibule or vagina. 12. Chronic use of narcotics or alcoholism during the last 5 years. |
Country | Name | City | State |
---|---|---|---|
United States | The Centers for Vulvovaginal Disorders | New York | New York |
United States | The Centers for Vulvovaginal Disorders | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Center for Vulvovaginal Disorders | EndoCeutics Inc. |
United States,
Archer DF, Labrie F, Bouchard C, Portman DJ, Koltun W, Cusan L, Labrie C, Côté I, Lavoie L, Martel C, Balser J; VVA Prasterone Group. Treatment of pain at sexual activity (dyspareunia) with intravaginal dehydroepiandrosterone (prasterone). Menopause. 2015 Sep;22(9):950-63. doi: 10.1097/GME.0000000000000428. — View Citation
Kingsberg S, Kellogg S, Krychman M. Treating dyspareunia caused by vaginal atrophy: a review of treatment options using vaginal estrogen therapy. Int J Womens Health. 2010 Aug 9;1:105-11. — View Citation
Labrie F, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Côté I, Parent J, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Balser J, Moyneur É; VVA Prasterone Research Group. Efficacy of intravaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause. Menopause. 2016 Mar;23(3):243-56. doi: 10.1097/GME.0000000000000571. — View Citation
Labrie F, Martel C, Pelletier G. Is vulvovaginal atrophy due to a lack of both estrogens and androgens? Menopause. 2017 Apr;24(4):452-461. doi: 10.1097/GME.0000000000000768. Review. — View Citation
Labrie F. Intracrinology. Mol Cell Endocrinol. 1991 Jul;78(3):C113-8. Review. — View Citation
Nappi RE, Palacios S. Impact of vulvovaginal atrophy on sexual health and quality of life at postmenopause. Climacteric. 2014 Feb;17(1):3-9. doi: 10.3109/13697137.2013.871696. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes from baseline in morphological content of vulvar and vaginal cells | Changes from baseline in density of androgen, estrogen and progesterone receptors. Unit of measure to be determined. | 2 years | |
Primary | Changes from baseline in morphological content of vulvar and vaginal cells | Changes from baseline in tissue steroid concentrations. Unit of measure to be determined. | 2 years | |
Primary | Changes from baseline in morphological content of vulvar and vaginal cells | Changes from baseline in blood steroid concentration. Unit of measure to be determined. | 2 years | |
Primary | Changes from baseline in protein content of vulvar and vaginal cells | Changes from baseline in mucin. Unit of measure to be determined. | 2 years | |
Primary | Changes from baseline in enzymatic content of vulvar and vaginal cells | Changes from baseline in enzymatic content (HSD17B5, HSD3B1, 5alphaRED2, aromatase, HDS17B1, sulfotransferase 2A1, sulfatase and UGT2B). All enzymes have the same unit of measure. Unit of measure to be determined. | 2 years | |
Primary | Changes from baseline in antigen content of vulvar and vaginal cells | Changes from baseline in PGP9.5. Unit of measure to be determined. | 2 years | |
Primary | Changes from baseline in antigen content of vulvar and vaginal cells | Changes from baseline in Ki-67 antigen. Unit of measure to be determined. | 2 years | |
Secondary | Mean change from baseline in subject's scores on pain severity subscale VPAQ | The Vulvar Pain Assessment Questionnaire (VPAQ) was developed to assess the dimensions of the pain experience in studies of chronic pain. It consists of 6 primary (pain severity, emotional response, cognitive response, and interference with life, sexual function, and self-stimulation/penetration) and 3 supplementary subscales (pain quality, coping skills, and partner factors). The pain severity subscale of the VPAQ consists of 3 pairs of verbal rating scale that test both pain intensity and pain affect. Each verbal rating scale is a 5-point scale with the following options: none=0, mild=1, moderate=2, severe=3, and worst possible=4. The calculated mean produces the overall score for the pain severity subscale ranging from 0-4 (4 is the worst score). | 2 years |
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