BMD Alterations and Bone and Muscle Parameters During Menstrual Cessation With GnRH
NCT ID: NCT04203212
Last Updated: 2021-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
41 participants
OBSERVATIONAL
2019-10-01
2020-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
Goserelin Acetate
Goserelin the a GnRH analog that will be administered to achieve menstrual cessation for 6 months
Control Group
20 age- and BMI-matched premenopausal, health women who will receive no treatment and be monitored for 6 months.
No interventions assigned to this group
Interventions
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Goserelin Acetate
Goserelin the a GnRH analog that will be administered to achieve menstrual cessation for 6 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. diseases or conditions that could affect bone and/or muscle metabolism
3. any medications that could affect bone and/or muscle metabolism
18 Years
45 Years
FEMALE
Yes
Sponsors
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251 Hellenic Air Force & VA General Hospital
OTHER
Aristotle University Of Thessaloniki
OTHER
424 General Military Hospital
OTHER
Responsible Party
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Athanasios D. Anastasilakis
Consultant of endocrinology
Principal Investigators
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Athanasios Anastasilakis, PhD
Role: PRINCIPAL_INVESTIGATOR
424 General Military Hospital
Locations
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424 General Military Hospital
Thessaloniki, , Greece
Countries
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References
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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.
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.
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.
Other Identifiers
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Menomyobone
Identifier Type: -
Identifier Source: org_study_id
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