Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
COL-1620 · 1 trial · 2 indications
Clinical pregnancy was defined as the presence of a fetal sac on transvaginal ultrasound (TVUS) during Week 5 or the presence of an extra-uterine pregnancy (as confirmed during surgery or by 2 positive serum beta-human chorionic gonadotropin (beta-hCG) results from Week 5). The clinical pregnancy rate was calculated as number of subjects who were clinically pregnant divided by the number of subjects who had at least 1 embryo transferred.
| Arm | Type | Description |
|---|---|---|
| COL-1620 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| COL-1620 | DRUG | The subjects will be administered with COL-1620 vaginal progesterone gel (1.125 grams of progesterone gel containing 90 milligram that is 8 percent \[%\] gel) vaginally once daily, from the day of ovum pick-up (OPU) until Week 12. |
| Gonadotropin-releasing hormone (GnRH) analogue | DRUG | Subjects will undergo conventional controlled ovarian stimulation (COS) therapy for in-vitro Fertilization and Embryo Transfer (IVF/ET) according to the Investigator's discretion using GnRH analogue (agonist or antagonist) preparation. |
| Follicle-stimulating hormone (FSH) | DRUG | Subjects will undergo conventional COS therapy for IVF/ET according to the Investigator's discretion using FSH containing preparation. |
| Human Chorionic Gonadotropin (hCG) | DRUG | Subjects will undergo conventional COS therapy for IVF/ET according to the Investigator's discretion using hCG preparation. |
Inclusion Criteria: * Japanese race * Woman with a history of infertility and in whom In-vitro fertilization and embryo transfer (IVF/ET) is indicated * The controlled ovarian stimulation (COS) therapy is gonadotropin-releasing hormone (GnRH) analogue (agonist or antagonist) in combination with a f...
COL-1620 is a small molecule being developed for luteal hormone supplementation in in-vitro fertilization. It is administered as a vaginal progesterone gel to support the luteal phase after embryo transfer. The drug is intended for use in women undergoing IVF procedures.
COL-1620 is being developed by Merck KGaA, a German multinational pharmaceutical company. The company's stock is traded over-the-counter under the ticker MKGAF. Merck KGaA is conducting clinical trials to evaluate the drug's efficacy and safety.
COL-1620 is in Phase 3 clinical development. A Phase 3 trial has been completed to evaluate its efficacy and safety. The drug is investigational and has not been approved by regulatory authorities. It is being studied for luteal hormone supplementation in in-vitro fertilization.
COL-1620 has one completed Phase 3 clinical trial with the identifier NCT01863680. The trial evaluated the efficacy and safety of COL-1620 vaginal progesterone gel in 178 female participants aged 20 years and older. The study was conducted in Japan and was not randomized or double-blinded.
COL-1620 is a vaginal progesterone gel formulation. The drug is being studied as a luteal hormone supplement for in-vitro fertilization. The Phase 3 trial specifically tested COL-1620 vaginal progesterone gel, indicating that the drug is delivered in this form for its intended use.