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open label, active-controlled, randomized, parallel group, comparative study.
This is a phase III comparative study to evaluate the effectiveness and safety of DA-3801 in treatment of the patients with WHO Group II anovulatory infertility failing to clomiphene citrate treatment. The study is conducted with following methods: open label, active-controlled, randomized, parallel group, comparative.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DA-3801 injection | Experimental | Recominant human follicle stimulating hormone 75 IU/day is injected for 14 days |
|
| Gonal-F® | Active Comparator | 75 IU/day is injected for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA-3801 Injection | Drug |
| ||
| Gonal-F® |
| Measure | Description | Time Frame |
|---|---|---|
| The ovulation rate after 3 cycles of the injection | 5 weeks maximum |
| Measure | Description | Time Frame |
|---|---|---|
| Total dose used, IU (International Unit) | 5 weeks | |
| Duration of stimulation, days | 5 weeks | |
| Threshold dose, IU |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eung Gi Min, M.D., Ph.D. | Dongguk University Hospital | Principal Investigator |
| Chang Suk Suh, M.D., Ph.D. | Seoul National University Bundang Hospital | Principal Investigator |
| Doo Seok Choi, M.D., Ph.D. | Samsung Medical Center | Principal Investigator |
| Chung Hoon Kim, M.D., Ph.D. | Asan Medical Center | Principal Investigator |
| Jong Min Park, M.D.,Ph.D. | Gachon University Gil Medical Center | Principal Investigator |
| Kyung Joo Hwang, M.D., Ph.D. | Ajou University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital Institutional Review Board | Seoul | 110-744 | South Korea |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| D000858 | Anovulation |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
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| ID | Term |
|---|---|
| C524162 | DA-3801 |
| C571801 | follitropin alfa |
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|
| 5 weeks |
| Number of follicles | Counter the number of follicles which are 12 mm, 15 mm, 18 mm in diameter | 5 weeks |
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |