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Compare Vaginal Estrogen and Platelet-rich Plasma Over Women With Genitourinary Syndrome of Menopause

M

Mackay Memorial Hospital

Status

Not yet enrolling

Conditions

Platelet-rich Plasma
Vaginal Atrophy
Estrogen Replacement Therapy
Menopause

Treatments

Drug: Vaginal estrogen supplement
Procedure: Platelet-rich plasma injection

Study type

Observational

Funder types

Other

Identifiers

NCT05483634
19MMHIS340e

Details and patient eligibility

About

The definition of Genitourinary Syndrome of Menopause (GSM) is the decline of estrogens during menopause results in symptoms and clinical signs from both systems. Estrogen and other hormones production decrease after menopause because the ovaries lose their effectiveness, leading to mucosal atrophy, reduced vaginal moisture, dysuria, urgency, recurrent infection, burning, pruritus and dyspareunia.

The treatment included vaginal estrogen supplement, vaginal hyaluronic acid supplement, vaginal laser, platelet rich plasma, etc. Observational cohort study will be used for study design, and questionnaire, pelvic examination, vaginal pap smear with maturation index (MI), vaginal pH, and other methods will be used for evaluation of the effectiveness and side effects.

Enrollment

40 estimated patients

Sex

Female

Ages

45 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Women with menopause
  • Patients with symptoms of genitourinary syndrome of menopause

Exclusion criteria

  • Genitourinary bleeding or infection without definitive diagnosis
  • Coagulopathy
  • Allergy to medication or therapy related with the treatment
  • Chronic disease that might influence outcome
  • Using medication that might influence outcome in 30 days
  • Using hormone or steroid within 8 weeks

Trial design

40 participants in 1 patient group

Genital urinary symptoms of menopause
Description:
Menopause for one year, or age above 45 with symptoms of GSM
Treatment:
Procedure: Platelet-rich plasma injection
Drug: Vaginal estrogen supplement

Trial contacts and locations

1

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Central trial contact

Hui-Hsuan Lau

Data sourced from clinicaltrials.gov

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