Status:
UNKNOWN
Safety and Tolerability of TWP-201 in Healthy Female Subjects
Lead Sponsor:
Shandong TheraWisdom Biopharma Co., Ltd.
Conditions:
Infertility
Eligibility:
FEMALE
18-42 years
Phase:
PHASE1
Brief Summary
This study is a randomized, double-blind, placebo-controlled, single dose, escalation, phase I clinical trial to evaluate the safety and tolerability of recombinant human follicle stimulating hormone ...
Eligibility Criteria
Inclusion
- Body weight ≥ 45 kg, 19 ≤ body mass index (BMI) ≤ 28 kg /m2;
- Women with sexual experience, potential fertility and regular menstrual cycle (25-34 days) (including boundary value);
- The levels of sex hormones were normal or abnormal without clinical significance at the time of screening;
- The physiological structure of uterus and bilateral ovaries was normal or abnormal by ultrasound examination, without clinical significance;
Exclusion
- Known the history of stage III / IV endometriosis, submucosal myoma and endocrine abnormality within 6 months before enrollment;
- Known the history of ovarian hyperstimulation syndrome (OHSS);
- Premature ovarian failure, decreased ovarian reserve function (Antral Follicle Counting \< 3), high ovarian response, polycystic ovary syndrome, unexplained vaginal bleeding or endometrial hyperplasia;
- Any FSH or HMG preparations were used within 3 months before the first study;
- Pregnancy or lactating women.
Key Trial Info
Start Date :
May 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04878705
Start Date
May 17 2021
End Date
December 31 2022
Last Update
July 19 2021
Active Locations (1)
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1
West China Second University Hospital, Sichuan University
Chengdu, Sichuan, China, 610041