Publications by authors named "J P Gotteland"
Background: Uterine fibroids are common non-cancerous neoplasm that cause heavy menstrual bleeding and other signs. Linzagolix is an oral gonadotropin-releasing hormone receptor antagonist taken once per day that dose-dependently suppresses gonadal steroids and might reduce uterine-fibroid-associated signs. Two phase 3 trials were conducted to confirm the efficacy and safety of linzagolix at full-suppression (200 mg) and partial-suppression (100 mg) doses with or without hormonal add-back therapy (1 mg oestradiol and 0·5 mg norethisterone acetate) compared with placebo for the treatment of symptomatic uterine fibroids.
View Article and Find Full Text PDFAims: To identify linzagolix doses, an oral GnRH receptor antagonist, that effectively lower oestradiol (E2) to relieve endometriosis-related pelvic pain without compromising bone health.
Methods: Integrated statistical, pharmacokinetic-pharmacodynamic and systems pharmacology models were developed from Phase 1 and 2 clinical trial data in healthy volunteers and patients, receiving linzagolix 25-200 mg daily or placebo, and analysed simultaneously. The main outcome measures were pelvic pain scores for dysmenorrhoea, nonmenstrual pelvic pain (NMPP), uterine bleeding and lumbar spine bone mineral density (BMD).
Article Synopsis
- The study looked at how a drug called nolasiban affects the uterus in women who are getting ready for pregnancy.
- Women were given either a placebo or two different doses of nolasiban, and their uterine contractions and blood flow were measured.
- The results showed that nolasiban helped reduce contractions and improve blood flow, especially at the higher dose, and it also changed the activity of certain genes linked to pregnancy.
Article Synopsis
- Nolasiban is a new medicine that helps improve fertility treatments by blocking oxytocin receptors.
- A study tested this medicine on 45 healthy women and checked how it affects their heart's electrical signals, specifically a measure called QTc.
- The results showed that nolasiban is safe for the heart and also found that certain hormones in women affect heart measurements.
Objective: To study the effect of a new investigational oral gonadotropin-releasing hormone antagonist, linzagolix, on endometriosis-associated pain (EAP).
Design: A multinational, parallel group, randomized, placebo-controlled, double-blind, dose-ranging trial.
Setting: Clinical centers.