None listed
Conditions
Interventions
Group B:The dosage of the first cycle of progesterone injection (II) is 50mg/day, completed according to the study protocol. After a washout period of at least 14 days, the dosage of the second cycle
Group A:The dosage of the first cycle of progesterone injection (II) is 25mg/day, completed according to the study protocol. After a washout period of at least 14 days, the dosage of the second cycle
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
Female
Age
45 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Healthy Chinese menopausal female volunteers aged 45-60 years (menopause is defined as spontaneous menopause for more than 1 year or more before enrollment, or bilateral oophorectomy (uterine preservation) for at least 1 year, and follicle stimulating hormone (FSH) levels > 40 IU/L and serum estradiol (E2) levels = 19 kg/m^2 and <= 25 kg/m^2; 4.Vital signs blood pressure, heart rate, etc. normal; 5.No bad habits of smoking and alcohol, no drug addiction; 6.Good communication with investigators and willingness to cooperate in completing the clinical trial; 7.Voluntarily signed informed consent;
Exclusion criteria
Exclusion criteria: 1.Identify any abnormalities during the screening period that may affect the study; 2.Clinically significant laboratory abnormalities identified during the screening period that were assessed as inappropriate for study participation by the investigator; 3.Participation in any other clinical drug trial within the last 3 months; 4.Any steroid hormone medication taken within 3 months; 5.Frequent or ongoing use of drugs that affect drug metabolism such as rifampicin, carbamazepine, griseofulvin, glibenclamide, phenobarbital, phenytoin, or herbal products containing St. John 's wort (or hypericum perforatum, hypericum perforatum), ketoconazole; 6.History of thromboembolism or thrombophlebitis, stroke, cerebral hemorrhage, or relevant history; 7.Serious cardiovascular problems; 8.Presence or suspected history of any malignancy, particularly sex hormone-dependent tumors, such as breast cancer, endometrial cancer, etc. 9.Blood system disorders, such as blood porphyria; 10.Severe hepatic dysfunction or related disorders; 11.Have had or who are having mental illness, depression, or epilepsy; 12.Known hypersensitivity to progesterone preparations or excipients hydroxypropyl ß cyclodextrin;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Histopathological changes of endometrial cycle;PK Parameters; | — |
Countries
China
Contacts
Public ContactChengyan Deng
Peking Union Medical College Hospital
Outcome results
None listed