A Trial to Compare Efficacy and Safety of Follitropin Delta Versus Placebo (Inactive Treatment) in the Treatment of Men With Idiopathic Infertility (Unexplained Reduction of Semen Quality) (ADAM)
Summary
The primary purpose of this trial is to investigate whether men with idiopathic infertility (unexplained reduction of semen quality), after being treated with a daily dose of 12 µg recombinant follicle stimulating hormone (rFSH) for 6 months, can improve the chance of spontaneous pregnancy observed in their female partners in comparison to placebo (inactive treatment). For more information, please visit the trial's website www.adamclinicaltrial.com (only applicable in the US).
Timeline
- Start
- 2022-08-16
- Primary completion
- 2024-10-05
- Completion
- 2024-10-23
Outcome
Outcome not reported
Stopped (Enrollment): “The probability of enrolling subjects in the trial in a reasonable timeframe was too low. The termination was not due to safety concerns nor changes in Ferring's Reproductive Medicine strategy or interest in developing treatments for Male Infertility”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Follitropin delta | Protein / enzyme biologic | 12 ug | Subcutaneous |