The Outcome of Chinese Women With Genitourinary Syndrome of Menopause Treated With Vaginal Dehydroepiandrosterone

NCT05434351 | Terminated

• 1 other identifier: CRE 2022.089
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Genitourinary syndrome of menopause (GSM) is a common condition with prevalence was up to 80%. Symptoms associated with GSM include vaginal or vulvar dryness, itchiness, dyspareunia, increased urinary frequency or urgency and dysuria. Although the symptoms are disturbing and causing a significant negative impact on quality of life, it is observed that only a minority of the women receive proper treatment. Treating these GSM-associated symptoms properly is important because these symptoms usually persist with time, unlike vasomotor symptoms of menopause which may subside spontaneously with time. The clinical efficacy and metabolism of vaginal DHEA has been evaluated in western population. However, there is lack of local data on the effectiveness of vaginal DHEA in treating Chinese women with GSM. Therefore, we aim at evaluating the clinical outcome of our participants who have moderate to severe symptoms of GSM who has been treated with vaginal DHEA.

Conditions

Genitourinary Syndrome of Menopause

Keywords

vaginal dehydroepiandrosterone (DHEA)

Outcome Measures

Primary Outcomes (1)

• The symptoms in Chinese women with moderate to severe symptoms of GSM.

  The symptoms of GSM were assessed by a visual analogue score (0 to 10) of items including vaginal itchiness, dryness, pain and hotness, dysuria, urinary urgency, stress urinary incontinence, urinary urge incontinence and dyspareunia. The higher scores mean a worse outcome.

  baseline

Secondary Outcomes (1)

• The clinical outcome in Chinese women with moderate to severe symptoms of GSM treated with vaginal DHEA

  12-week

Study Arms (1)

Chinese women with moderate to severe symptoms of genitourinary syndrome of menopause

It is a single-group study.

Other: vaginal dehydroepiandrosterone

Interventions

vaginal dehydroepiandrosterone OTHER

the clinical outcome in Chinese women with moderate to severe symptoms of GSM treated with vaginal DHEA for 12 weeks will be evaluated

Chinese women with moderate to severe symptoms of genitourinary syndrome of menopause

Eligibility Criteria

• Sex: female
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All menopause Chinese women with moderate to severe symptoms of GSM and treated with vaginal DHEA were enrolled for analysis. Menopause is defined as cessation of menses for more than 1 year in women with uterus, or follicle stimulating hormone (FSH) ≥ 40 in women with no menses more than 6 months. Moderate to severe symptoms of GSM was defined as a visual analogue score (VAS) of 4 or above of any item including vaginal itchiness, dryness, pain and hotness, dysuria, urinary urgency, stress urinary incontinence, urinary urge incontinence and dyspareunia.

You may qualify if:

• All menopause Chinese women who have moderate to severe symptoms of Genitourinary syndrome of menopause (GSM) and treated with vaginal DHEA

You may not qualify if:

• Genitourinary syndrome of menopause (GSM) due to other differential diagnosis such as candidiasis / lichen sclerosis/urodynamic stress incontinence/ detrusor over-activity.
• Amenorrhoea due to medication
• History of hormonal sensitive cancer, active or history of thromboembolic events, unexplained abnormal uterine bleeding
• Endometrial thickness ≥ 5mm

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, 852, Hong Kong

Location

Related Publications (7)

• The NAMS 2020 GSM Position Statement Editorial Panel. The 2020 genitourinary syndrome of menopause position statement of The North American Menopause Society. Menopause. 2020 Sep;27(9):976-992. doi: 10.1097/GME.0000000000001609.

  PMID: 32852449 BACKGROUND

• Binkowska M, Paszkowski T, Violetta SP, Wilczak M, Zgliczynski W. Position statement by Experts of the Polish Menopause and Andropause Society, and the Polish Society of Aesthetic and Reconstructive Gynaecology on the medicinal product Intrarosa(R). Prz Menopauzalny. 2019 Dec;18(3):127-132. doi: 10.5114/pm.2019.90113. Epub 2019 Dec 20. No abstract available.

  PMID: 31975978 BACKGROUND

• Labrie F, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Cote I, Parent J, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Balser J, Moyneur E; 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.

  PMID: 26731686 RESULT

• Archer DF, Labrie F, Bouchard C, Portman DJ, Koltun W, Cusan L, Labrie C, Cote 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.

  PMID: 25734980 RESULT

• Labrie F, Archer DF, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dube R, Cote I, Labrie C, Lavoie L, Berger L, Gilbert L, Martel C, Balser J. Intravaginal dehydroepiandrosterone (prasterone), a highly efficient treatment of dyspareunia. Climacteric. 2011 Apr;14(2):282-8. doi: 10.3109/13697137.2010.535226. Epub 2011 Jan 18.

  PMID: 21244215 RESULT

• Labrie F, Derogatis L, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Cote I, Parent J, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Balser J, Moyneur E; Members of the VVA Prasterone Research Group. Effect of Intravaginal Prasterone on Sexual Dysfunction in Postmenopausal Women with Vulvovaginal Atrophy. J Sex Med. 2015 Dec;12(12):2401-12. doi: 10.1111/jsm.13045. Epub 2015 Nov 23.

  PMID: 26597311 RESULT

• Labrie F, Cusan L, Gomez JL, Cote I, Berube R, Belanger P, Martel C, Labrie C. Effect of intravaginal DHEA on serum DHEA and eleven of its metabolites in postmenopausal women. J Steroid Biochem Mol Biol. 2008 Sep;111(3-5):178-94. doi: 10.1016/j.jsbmb.2008.06.003. Epub 2008 Jun 12.

  PMID: 18598765 RESULT

Study Officials

• Yan Yan Lau

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: May 22, 2022
• First Posted: June 28, 2022
• Study Start: August 1, 2022
• Primary Completion: February 23, 2023
• Study Completion: February 23, 2023
• Last Updated: July 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)