Effects of vaginal administration of conjugated estrogens tablet on sexual function in postmenopausal women with sexual dysfunction: a double-blind, randomized, placebo-controlled trial

Phase 2

• Conditions: sexual function in postmenopausal women; conjugated estrogens tablet; vaginal administration; sexual function; postmenopausal women; sexual dysfunction; Vaginal pH; Vaginal atrophy symptoms; Vaginal maturation index; Number of lactobacilli&#44

• Registration Number: TCTR20180219001
• Lead Sponsor: Ratchadapiseksompot Endowment Fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-19
• Study Completion: 2019-03-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Being amenorrhea for at least 1 year (according to diagnostic definition of menopause by WHO)
Consent was given
Vaginal pH >5
Atleast on vaginal atrophic symptoms in moderate intensity
TFSFI score not over 26.5
Well communicable in Thai
History of engagement in sexual intercourse at least 2 times a month

Exclusion Criteria

Pathologic cause of menopause : primary ovarian insufficiency, underwent oophorectomy, radiation/chemotherapy induced menopause
History of receiving hormone or other therapy affecting vaginal mucosa
History of abnormal vaginal discharge or bleeding not yet evaluated nor treated
History of vaginal or cervical surgery within 3 months prior to enrollment
Personal or family history of estrogen related malignancy
Having contraindication for hormonal use
History of sex steroid hormone / steroid use within 2 months prior to enrollment
History of psychiatric condition
Having active sexual partner with history of sexual dysfunction

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sexual function in postmenopausal women at 12 weeks after starting of the intervention FSFI score

Secondary Outcome Measures

Name	Time	Method
Vaginal atrophy symptoms (The most bothersome symptom) at 12 weeks after starting of the intervention Vaginal atrophy symptoms (The most bothersome symptom),Vaginal pH at 12 weeks after starting of the intervention pH paper,The number of lactobacilli at 12 weeks after starting of the intervention Gram staining and count under light microscope with magnification,vaginal maturation index at 12 weeks after starting of the intervention Staining and count under light microscope with magnification,Normal Flora Index at 12 weeks after starting of the intervention Gram staining and count under light microscope with magnification