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

4

424 General Military Hospital

Status

Completed

Conditions

Muscle
Bone Metabolism
Endometriosis
Bone Density

Treatments

Drug: Goserelin Acetate

Study type

Observational

Funder types

Other

Identifiers

NCT04203212
Menomyobone

Details and patient eligibility

About

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

Full 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.

Enrollment

41 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Premenopausal women with surgically verified endometriosis

Exclusion criteria

  1. Secondary osteoporosis
  2. diseases or conditions that could affect bone and/or muscle metabolism
  3. any medications that could affect bone and/or muscle metabolism

Trial design

41 participants in 2 patient groups

Endometriosis Group
Description:
20 premenopausal women with surgically verified endometriosis who 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.
Treatment:
Drug: Goserelin Acetate
Control Group
Description:
20 age- and BMI-matched premenopausal, health women who will receive no treatment and be monitored for 6 months.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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