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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02491437 | A Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Crinone 8% Intravaginal Progesterone Gel 90 mg Daily for Luteal Support in In-Vitro Fertilization (LOTUS II) | PHASE3 | COMPLETED | 1,034 | — | — | Jul 1, 2015 | May 1, 2017 | Oct 1, 2019 | 40 | Australia, Belgium +8 |
| NCT01850030 | A Multicenter Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Intravaginal Micronized Progesterone Capsules 600 mg Daily for Luteal Support in In-Vitro Fertilization | PHASE3 | COMPLETED | 1,070 | — | — | Aug 1, 2013 | Mar 1, 2016 | Jan 2, 2018 | 40 | Austria, Belgium +5 |
Pregnancy rate defined as the presence of fetal heart beats at 12 weeks' gestation determined by transvaginal ultrasound.
Percentage of participants being pregnant as measured by the presence of fetal heart beats at 12 weeks´gestation using transvaginal ultrasound
| Arm | Type | Description |
|---|---|---|
| Dydrogesterone tablets 3x10 mg | EXPERIMENTAL | Dydrogesterone tablets 3x10 mg |
| Crinone 8% intravaginal progesterone gel 90 mg | EXPERIMENTAL | Crinone 8% intravaginal progesterone gel 90 mg |
| Dydrogesterone 30 mg | EXPERIMENTAL | - |
| Micronized Progesterone 600 mg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Dydrogesterone 30 mg | DRUG | Oral Dydrogesterone 10 mg tablets tid |
| intravaginal progesterone gel 90 mg | DRUG | - |
| Micronized Progesterone 600 mg | DRUG | Intravaginal micronized progesterone 200 mg capsules tid |
| Placebo progesterone | DRUG | Placebo intravaginal micronized progesterone 200 mg capsules tid |
| Placebo dydrogesterone | DRUG | placebo oral dydrogesterone 10 mg tablets tid |
Inclusion Criteria: * Signed informed consent; * Premenopausal females, age \> 18 years \< 42 years * Non-smokers. For females who were past smokers, they must have stopped tobacco usage for at least 3 months prior screening visit * Early follicular phase (Day 2-4) Follicle stimulating hormone (FSH...