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 an investigational small molecule being studied for female infertility and recurrent miscarriage. In clinical trials, it is evaluated as oral luteal support during in-vitro fertilization and as a treatment during pregnancy in women with recurrent miscarriage. The drug is in Phase 3 development and is not yet approved.
Dydrogesterone is being developed by Abbott Laboratories, a company traded on the New York Stock Exchange under the ticker ABT. The drug is currently in Phase 3 clinical development for female infertility and recurrent miscarriage.
Dydrogesterone is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. All completed trials for the drug are Phase 3 studies, and it is being studied for female infertility and recurrent miscarriage.
Dydrogesterone has been studied in three Phase 3 clinical trials. NCT00193674 examined oral dydrogesterone in women with recurrent miscarriage. NCT01850030 compared oral dydrogesterone 30 mg daily to intravaginal micronized progesterone for luteal support in IVF. NCT02491437 compared oral dydrogesterone to Crinone 8% intravaginal progesterone gel for luteal support in IVF.
Dydrogesterone is a distinct oral progestogen being compared to other progesterone treatments in clinical trials. In studies, it was tested against intravaginal micronized progesterone capsules and Crinone 8% intravaginal progesterone gel for luteal support in in-vitro fertilization. It is not the same as these comparators.