Safety and Efficacy of YB-1113 in Treatment of POI
- Conditions
- POI
- Registration Number
- NCT05494723
- Lead Sponsor
- Bright Cell, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- Female
- Target Recruitment
- 6
Key Inclusion Criteria:<br><br> 1. Female, 18 to <40 years old, who are seeking fertility or preservation of fertility<br><br> 2. Oligo/Amenorrhea for at least 4 months<br><br> 3. At least two menopausal FSH levels (= 25 IU/L) with 4 to 6 weeks interval.<br><br> 4. AMH levels = 1.0 ng/mL (measured on day 2-5 of the menstrual period).<br><br> 5. Subjects who are generally healthy by laboratory tests (normal complete blood count<br> (CBC), comprehensive metabolic panel (CMP), and urinalysis) at screening<br><br> 6. For subjects who had contraception before, the duration of amenorrhea should be more<br> than 3 months after discontinuation of the oral contraception pill (OCP) or more<br> than 6 months after discontinuation of Depo Provera (or similar) therapies<br><br>Key Exclusion Criteria:<br><br> 1. <br><br> 1. Primary amenorrhea or FSH = 40 IU/L<br><br> 2. Presence of contraindications to pregnancy<br><br> 3. POI due to cytotoxic chemotherapy or radiation therapy<br><br> 4. Subjects with FMR1 premutation (fragile X syndrome), a BMP15 mutation or family<br> history of POI<br><br> 5. Subjects under hormonal treatments including hormone replacement therapy (HRT) for<br> osteoporosis, cardiovascular disease, or recalcitrant vasomotor symptomatology.<br><br> 6. Washout period less than 3 months for HRT.<br><br> 7. Subjects with a history of breast cancer or other estrogen responsive cancer.<br><br> 8. Subjects with existing malignant neoplasm, under active management for malignant<br> neoplasm or under active surveillance for malignant neoplasm.<br><br> 9. Subjects with history of thromboembolic events such as pulmonary embolism, stroke,<br> or ischemic heart disease<br><br> 10. Subjects with uncontrolled hypertension, kidney disease, liver disease, or<br> polycystic ovary syndrome (PCOS)<br><br> 11. Subjects with endocrinopathies including Cushing's disease, thyroid disease,<br> congenital adrenal hyperplasia and hyperprolactinemia.<br><br> 12. Subjects under active management for autoimmune disease.<br><br> 13. Subjects with intra-uterine devices (IUDs).<br><br> 14. Subjects who are pregnant, breastfeeding, or whose urinary pregnancy test is<br> positive before participation in the study.<br><br> 15. Subjects who are allergic to low-molecular-weight heparin sodium or human albumin.<br><br> 16. Subjects with polyglandular autoimmune disease or other conditions require chronic<br> administration of steroids higher than 30 mg/day of hydrocortisone or its equivalent<br><br> 17. Subjects with hereditary or acquirement coagulopathies, including but not limited to<br> hemophilia, Von Willebrand disease, liver disease, Vitamin K deficiency, and<br> platelet disorders.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events (AE)
- Secondary Outcome Measures
Name Time Method Blood anti-Mu¨llerian hormone (AMH) level;Follicle-stimulating hormone (FSH) and estradiol (E2) levels;Antral follicle counts (AFC)