A Phase 1 interventional study of Lutrepulse in Amenorrhea, Fertility and Infertility, sponsored by Ferring Pharmaceuticals. Withdrawn at 1 site in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-14.
Sponsored by Ferring Pharmaceuticals · Phase 1, Interventional, and Treatment
One of the Causes of Amenorrhea is hypothalamic amenorrhea, which is a deficiency in the amplitude and/or frequency of endogenous Gonadotropin-releasing hormone (GnRH) Pulses. The results of this leads to anovulation and cessation of the menstrual cycle. Pulsatile GnRH has been widely used in the United States (US), Canada, and Europe for almost 40 years in the treatment of primary hypothalamic amenorrhea. It has a favorable safety profile and a high degree of effectiveness in enabling ovulation and spontaneous pregnancy. At the moment there are no other GnRH products on the market, nor are there any other drugs marketed for induction of ovulation in women with primary hypothalamic amenorrhea in the US, creating a clear unmet medical need. The goal of this trial is to characterize the exposure variability of GnRH when administered via the OmniPod.
80 studies on the registry are indexed under Amenorrhea; 13 are open to participants now.
Browse Amenorrhea studies →Ferring Pharmaceuticals is the lead sponsor of 244 studies on the registry; 4 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 13 (93%) have results posted.
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Exclusion Criteria
Single-dose (1 pulse) LUTREPULSE Omnipod 20ug/pulse
Drug: Lutrepulse
Part 1 - Single dose (1 pulse) LUTREPULSE Omnipod 20ug/pulse Part 2 - multiple doses (6 pulse) LUTREPULSE Omnipod 20ug/pulse
Drug: Lutrepulse
Lutrepulse administered via the OmniPod delivery pump
Cmax: maximum observed plasma concentration from Part 1- Pulse 1
Time frame: Up to 5 days
AUC0-t: area under the concentration-time profile to the last quantified concentration from Part 1- Pulse 1
Time frame: Up to 5 days
AUC0-infinity: area under the concentration-time curve to infinity from Part 1- Pulse 1
Time frame: Up to 5 days
tmax: time to maximum plasma concentration from Part 1- Pulse 1
Time frame: Up to 5 days
λz; terminal elimination rate constant from Part 1- Pulse 1
Time frame: Up to 5 days
t½; terminal elimination half-life from Part 1- Pulse 1
Time frame: Up to 5 days
Cmax: maximum observed plasma concentration from Part 2 - Pulse 6
Time frame: Up to 4 days
AUC0-t: area under the concentration-time profile to the last quantified concentration from Part 2 - Pulse 6
Time frame: Up to 4 days
AUCtau: area under the concentration-time profile at steady-state from Part 2 - Pulse 6
Time frame: Up to 4 days
tmax: time to maximum plasma concentration from Part 2 - Pulse 6
Time frame: Up to 4 days
λz; terminal elimination rate constant from Part 2 - Pulse 6
Time frame: Up to 4 days
t½; terminal elimination half-life from Part 2 - Pulse 6
Time frame: Up to 4 days
Plan to share: No
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This study is withdrawn, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Ferring Pharmaceuticals