Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dydrogesterone · 3 trials · 2 indications
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 | - |
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| 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 |
| Dydrogesterone | DRUG | 20 mg/day, oral |
| Placebo | DRUG | Placebo |
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...
Dydrogesterone is a small molecule progesterone receptor agonist developed by Abbott Laboratories for female infertility and recurrent miscarriage. It is used as luteal support in in-vitro fertilization and in the treatment of recurrent miscarriage. It is also known as dydrogesterone 30 mg.
Dydrogesterone targets the progesterone receptor (PGR) and acts as an agonist. By binding to PGR, it mimics the effects of endogenous progesterone, supporting the luteal phase and early pregnancy. This mechanism underlies its use in female infertility and recurrent miscarriage.
Dydrogesterone is developed by Abbott Laboratories, which trades under the ticker ABT. Abbott is the company associated with the clinical development of dydrogesterone 30 mg for female infertility and recurrent miscarriage.
Dydrogesterone is in Phase 3 clinical development. It is investigational and has been studied in completed Phase 3 trials. The development program includes two completed Phase 3 trials in female infertility and one completed Phase 3 trial in recurrent miscarriage.
Dydrogesterone has been studied in three completed Phase 3 trials. NCT02491437 (LOTUS II) compared oral dydrogesterone 30 mg daily with Crinone 8% gel for luteal support in IVF. NCT01850030 compared it with intravaginal micronized progesterone capsules. NCT00193674 evaluated oral dydrogesterone in women with recurrent miscarriage.