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Oral GDC-0077 in Premature Ovarian Insufficiency
Sponsor: Women's Hospital School Of Medicine Zhejiang University
Summary
This is a single-center, single-arm, exploratory clinical trial evaluating the safety and potential effect of oral GDC-0077 on ovarian function in women with premature ovarian insufficiency (POI). GDC-0077 is an oral, highly selective PI3Kα inhibitor. Preclinical data from this research group showed that PI3Kα inhibition increased secondary and antral follicle counts in aged mice and promoted follicle development in cultured mouse ovaries. Twelve participants with POI will receive GDC-0077 9 mg orally three times weekly (Monday, Wednesday, Friday) for 3 weeks. The primary safety focus includes hyperglycemia, stomatitis/mucositis, and diarrhea. Ovarian function will be assessed by change in antral follicle count (AFC) from baseline at 3 months after treatment initiation, along with FSH, AMH, ovarian volume, and return of spontaneous menses.
Official title: A Single-Center, Single-Arm, Exploratory Clinical Trial of Oral Inavolisib in Patients With Premature Ovarian Insufficiency
Key Details
Gender
FEMALE
Age Range
20 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2026-10-30
Completion Date
2027-12-30
Last Updated
2026-10-29
Healthy Volunteers
No
Conditions
Interventions
GDC-0077
GDC-0077 9 mg film-coated tablet, oral, three times weekly (Monday/Wednesday/Friday), for 3 consecutive weeks. If a dose is missed, it should be taken as soon as remembered unless the next scheduled dose is within 12 hours, in which case the missed dose should be skipped.