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A prospective clinical study on the observation and treatment of menopausal women

A prospective clinical study on the observation and treatment of menopausal women

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038947
Enrollment
Unknown
Registered
2020-10-10
Start date
2020-10-09
Completion date
Unknown
Last updated
2021-01-05

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

Conditions

Menopausal disease

Interventions

Group 1:Femoston 1/0
Group 2:None

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
42 Years to 52 Years

Inclusion criteria

Inclusion criteria: a) Women aged 42-52 years. b) Intact uterus, visible in both ovaries under ultrasound. c) The difference in the length of the adjacent menstrual cycle is more than 7 days, it is repeated in 10 menstrual cycles, and there has been at least one menstrual cycle in the past 3 months. d) Menopausal symptoms are obvious, and the menopausal symptom scale (modified Kupperman score) >= 14 points. e) TCT results are normal within one year or TCT and HPV results are normal within three years. f) Patients who are willing to participate in this study and sign the informed consent.

Exclusion criteria

Exclusion criteria: a) The presence of various malignant tumors or suspected malignant tumors (tumor marker examination results or breast ultrasound or pelvic ultrasound indicating suspected malignant tumors); b) A history of thrombosis within 6 months; c) Used sex hormone drugs (including various estrogen-containing drugs or compound oral contraceptives) that affect ovarian function in the recent 2 months; d) Used traditional Chinese or plant drugs in the past two months (such as Kuntai capsule, Xiangshao granules, Lifumin and other similar drugs) to affect the menopausal symptoms, as well as anti-anxiety and depression drugs and western drugs; e) A history of drug allergy or allergic constitution that may endanger life; f) Transaminase (ALT) and creatinine (Cr) exceeding 2 times of the normal value; g) Uterine fibroids >= 5cm; h) Body mass index >= 28 kg/m2; i) Subjects who are participating in other clinical trials or who have participated in other clinical trials within 3 months; j) Other circumstances in which the physician considers it inappropriate to participate in the study.

Design outcomes

Secondary

MeasureTime frame
PSQI sleep score, depression and anxiety score, sexual function scale;physical examination;Vaginal microecological detection;sex hormone;BMD(bone mineral density);ultrasound;Menstrual diary, symptom diary;

Primary

MeasureTime frame
Kupperman Score Scale;

Countries

China

Contacts

Public ContactZhu Lan

Department of Obstetrics and Gynecology, Peking Union Medical College Hospital

zhu_julie@vip.sina.com+86 18612671818

Outcome results

None listed

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