Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06048536 | Dose-finding Study of MR-130A-01 Contraceptive Transdermal Patch | PHASE2 | COMPLETED | 168 | — | — | Dec 22, 2023 | Jan 18, 2024 | Nov 29, 2024 | 1 | Germany |
A responder is a subject with no ovulation. A responder is a subject with no ovulation. Ovulation during treatment is defined as a Hoogland-Skouby score 5 or 6 in combination with fulfilment of Landgren criterion.
A responder is a subject with no ovulation. A responder is a subject with no ovulation. Ovulation during treatment is defined as a Hoogland-Skouby score 5 or 6 in combination with fulfilment of Landgren criterion.
| Arm | Type | Description |
|---|---|---|
| Norelgestromin low dose 2.43mg 28/0 regimen non-Obese | EXPERIMENTAL | - |
| Norelgestromin mid dose 3.64mg 28/0 regimen non-Obese | EXPERIMENTAL | - |
| Norelgestromin high dose 4.86mg 28/0 regimen non-Obese | EXPERIMENTAL | - |
| Norelgestromin high dose 4.86mg 21/7 regimen non-Obese | EXPERIMENTAL | - |
| Norelgestromin mid dose 3.64mg 28/0 regimen Obese | EXPERIMENTAL | - |
| Norelgestromin high dose 4.86mg 28/0 regimen Obese | EXPERIMENTAL | - |
| Norelgestromin high dose 4.86mg 21/7 regimen Obese | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| MR-130A-01 Transdermal patch | DRUG | MR-130A-01 transdermal patch, containing 2.43 mg Norelgestromin, will be worn 28 days per cycle with no patch free period. |
Inclusion Criteria: 1. Healthy, post-menarcheal and premenopausal women of age 18 to 35 years inclusive). 2. BMI ≥18.0 kg/m2 at screening examination. 3. Subjects must be in good physical and mental health as determined by vital signs, medical history, and physical and gynecological examination, as...