Does a once-daily regimen of linzagolix, a new oral gonadotrophin-releasing hormone (GnRH) antagonist, given at a fully suppressive dose (200 mg) for 12 weeks, followed by a partially suppressive dose (100 mg) for a further 12 weeks, reduce adenomyotic uterine size and associated symptoms?
Eight women (aged 37–45 years) with adenomyosis confirmed by magnetic resonance imaging (MRI) were enrolled in a single-centre, open-label pilot study. The primary efficacy end-point was the change in uterine volume on MRI at 24 weeks. Secondary efficacy end-points included serum oestradiol, overall pelvic pain, dysmenorrhoea, non-menstrual pelvic pain, dyspareunia, dyschezia and quality of life (QoL). Bone mineral density (BMD) was assessed at baseline and 24 weeks.
At baseline, uterine volume (mean ± SD) was 333 ± 250 cm3. After 24 weeks, it was 204 ± 126 cm3, a reduction of 32% from baseline (P = 0.0057). After 12 weeks, it was 159 ± 95 cm3, a reduction of 55% (P < 0.0001). Median serum oestradiol was suppressed below 20 pg/ml during the 12 weeks on 200 mg linzagolix, and maintained below 60 pg/ml on 100 mg linzagolix. Improvements in overall pelvic pain, dysmenorrhoea, non-menstrual pelvic pain, dyspareunia, dyschezia and QoL were observed. Mean percentage change in BMD loss at 24 weeks was –2.4%, –1.3% and –4.1% for the spine, femoral neck and total hip, respectively. The most common adverse events were hot flushes.
A once-daily regimen of 200 mg linzagolix for 12 weeks and then 100 mg for another 12 weeks decreased adenomyotic uterine volume and improved associated symptoms.
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Jacques Donnez is Professor Emeritus at the Catholic University of Louvain and has been Director of Society of Research on Infertility in Brussels, Belgium, since 2012. His research interests are tubal infertility, endometriosis and ovarian cryopreservation and transplantation. He has published over 700 original articles in peer-reviewed journals.
Published online: October 02, 2021
Accepted: September 24, 2021
Received in revised form: August 30, 2021
Received: July 22, 2021Declaration: J.D. is member of the SAB of Preglem and Obseva. M.B., E.B., E.G., S.C., A.H. and E.L. are employees and/or stockholders of ObsEva. O.D. reports no financial or commercial conflicts of interest.
© 2021 Published by Elsevier Ltd on behalf of Reproductive Healthcare Ltd.