Trials / Unknown
UnknownNCT05738382
Efficacy and Safety of BG2109 During Controlled Ovarian Hyperstimulation in Female Subjects Undergoing ART Procedures
A Randomized, Double-blind, Open for Active Comparator, Parallel, Multi-center Phase II Study to Explore the Efficacy, Safety and Tolerability of BG2109 Compared With Cetrorelix During COH in Female Subjects Undergoing ART Procedures
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- Sponsor
- Bio Genuine (Shanghai) Biotech Co., Ltd. · Industry
- Sex
- Female
- Age
- 20 Years – 39 Years
- Healthy volunteers
- Not accepted
Summary
To explore the optimal effective daily dose of BG2109 to suppress premature luteinizing hormone (LH) surge during COH in female subjects undergoing ART procedures.
Detailed description
This study is a randomized, double-blind, open for active comparator, parallel, multi-center phase II dose-finding clinical study to explore the efficacy, safety and tolerability of different doses of BG2109 compared with Cetrorelix during Controlled Ovarian Hyperstimulation (COH) in Chinese female subjects undergoing Assisted Reproductive Technology (ART) procedures.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BG2109 | oral administration once daily |
| DRUG | Cetrorelix | 0.25 mg, Subcutaneous injection once daily. |
Timeline
- Start date
- 2023-08-01
- Primary completion
- 2024-06-01
- Completion
- 2024-12-01
- First posted
- 2023-02-22
- Last updated
- 2023-07-27
Locations
10 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05738382. Inclusion in this directory is not an endorsement.