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Study on the clinical efficacy of promestriene vaginal soft capsules for genitourinary syndrome of menopause

Study on the clinical efficacy of promestriene vaginal soft capsules for genitourinary syndrome of menopause

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031218
Enrollment
Unknown
Registered
2020-03-24
Start date
2020-06-30
Completion date
Unknown
Last updated
2020-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genitourinary syndrome of menopause

Interventions

single arm:The subjects placed promestriene vaginal soft capsules in the deep part of the vagina every night before going to bed, and used it for 20 consecutive days as a course of treatment, and bega

Sponsors

The Sixth People's Hospital Affiliated to Shanghai Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 40~65 years; 2. Patients with clinical manifestations and physical signs of postmenopausal urogenital syndrome; 3. Patients who voluntarily participate in the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with known or suspected breast cancer or estrogen dependent malignancy; 2. Patients with irregular vaginal bleeding of unknown causes; 3. Patients with thromboembolic diseases; 4. Patients who are allergic to any component of proestrene vaginal gel; 5. Patients taking estrogen or other steroids in the recent three months; 6. Patients with vaginal medication, vaginal washing and gynecological examination in the recent week; 7. Pregnant, pregnant or lactating patients; 8. Patients with serious organic diseases; 9. Patients who have been included in other studies and conflict with this study.

Design outcomes

Primary

MeasureTime frame
GSM Rating Scale;VHIS;Vaginal microbial sequencing;Vaginal discharge examination;

Secondary

MeasureTime frame
menopausal rating scale;

Countries

China

Contacts

Public ContactMinfang Tao

The Sixth People's Hospital Affiliated to Shanghai Jiaotong University

taomf@sjtu.edu.cn+86 18930177770

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026