NCT04203212

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 18, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

January 12, 2021

Status Verified

January 1, 2021

Enrollment Period

1.2 years

First QC Date

December 15, 2019

Last Update Submit

January 11, 2021

Conditions

EndometriosisBone DensityMuscleBone Metabolism

Keywords

endometriosisbone mineral densitymyokinessclerotinperiostin

Outcome Measures

Primary Outcomes (2)

  • lumbar spine BMD

    Bone mineral density changes at the lumbar spine measured by dual-energy absorptiometry

    between baseline and 6 months after goserelin initiation

  • lumbar spine BMD

    Bone mineral density changes at the lumbar spine measured by dual-energy absorptiometry

    between baseline and 6 months after goserelin discontinuation

Secondary Outcomes (9)

  • femoral neck BMD

    between baseline and 6 months after goserelin initiation

  • femoral neck BMD

    between baseline and 6 months after goserelin discontinuation

  • sclerostin

    0,6,12 months

  • periostin

    0,3,6,12 months

  • irisin

    0,3,6,12 months

  • +4 more secondary outcomes

Study Arms (2)

Endometriosis Group

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.

Drug: Goserelin Acetate

Control Group

20 age- and BMI-matched premenopausal, health women who will receive no treatment and be monitored for 6 months.

Interventions

Goserelin AcetateDRUG

Goserelin the a GnRH analog that will be administered to achieve menstrual cessation for 6 months

Also known as: GnRH analog
Endometriosis Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPremenopausal women
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Premenopausal women with surgically verified endometriosis

You may not qualify if:

  • Secondary osteoporosis
  • diseases or conditions that could affect bone and/or muscle metabolism
  • any medications that could affect bone and/or muscle metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

424 General Military Hospital

Thessaloniki, 56429, Greece

Location

Related Publications (3)

  • Paoletti AM, Serra GG, Cagnacci A, Vacca AM, Guerriero S, Solla E, Melis GB. Spontaneous reversibility of bone loss induced by gonadotropin-releasing hormone analog treatment. Fertil Steril. 1996 Apr;65(4):707-10.

    PMID: 8654625BACKGROUND

  • Waibel-Treber S, Minne HW, Scharla SH, Bremen T, Ziegler R, Leyendecker G. Reversible bone loss in women treated with GnRH-agonists for endometriosis and uterine leiomyoma. Hum Reprod. 1989 May;4(4):384-8. doi: 10.1093/oxfordjournals.humrep.a136912.

    PMID: 2526152BACKGROUND

  • Taga M, Minaguchi H. Reduction of bone mineral density by gonadotropin-releasing hormone agonist, nafarelin, is not completely reversible at 6 months after the cessation of administration. Acta Obstet Gynecol Scand. 1996 Feb;75(2):162-5. doi: 10.3109/00016349609033310.

    PMID: 8604604BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum samples

MeSH Terms

Conditions

Endometriosis

Interventions

GoserelinGonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Athanasios Anastasilakis, PhD

    424 General Military Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant of endocrinology

Study Record Dates

First Submitted

December 15, 2019

First Posted

December 18, 2019

Study Start

October 1, 2019

Primary Completion

December 1, 2020

Study Completion

December 31, 2020

Last Updated

January 12, 2021

Record last verified: 2021-01

Locations

GR(1)