NCT04203212

BMD Alterations and Bone and Muscle Parameters During Menstrual Cessation With GnRH

Bone Mineral Density Alterations and Correlations With Bone and Muscle Metabolism Parameters During Menstrual Cessation Due to GnRH Therapy and After Menstrual Restoration

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 41 (actual)
• Sponsor: 424 General Military Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The investigators aim to investigate the effect of menstrual cessation in women with endometriosis treated with GnRH analogs for 6 months on bone mineral density and bone and muscle metabolism parameters and subsequently the effects of menstrual restoration after GnRH analogs discontinuation on the above measured parameters

Detailed description

Prospective, open-label, controlled 12month observational study Premenopausal women with surgically verified endometriosis will receive goserelin 1 injection per month for 6 months. Subsequently goserelin will be discontinued and patients will be monitored for another 6 months after menstrual restoration. Age- and BMI-matched premenopausal, health women will serve as controls. Controls will receive no treatment.

Conditions

• Endometriosis
• Bone Density
• Muscle
• Bone Metabolism

Interventions

Type	Name	Description
DRUG	Goserelin Acetate	Goserelin the a GnRH analog that will be administered to achieve menstrual cessation for 6 months

Timeline

• Start date: 2019-10-01
• Primary completion: 2020-12-01
• Completion: 2020-12-31
• First posted: 2019-12-18
• Last updated: 2021-01-12

Locations

1 site across 1 country: Greece