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| Name | Class |
|---|---|
| 251 Hellenic Air Force & VA General Hospital | OTHER |
| Aristotle University Of Thessaloniki | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| Control Group | 20 age- and BMI-matched premenopausal, health women who will receive no treatment and be monitored for 6 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Goserelin Acetate | Drug | Goserelin the a GnRH analog that will be administered to achieve menstrual cessation for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| femoral neck BMD | Bone mineral density changes at the femoral neck measured by dual-energy absorptiometry | between baseline and 6 months after goserelin initiation |
| femoral neck BMD | Bone mineral density changes at the femoral neck measured by dual-energy absorptiometry |
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Inclusion Criteria:
Premenopausal women with surgically verified endometriosis
Exclusion Criteria:
Premenopausal women
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
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| Name | Affiliation | Role |
|---|---|---|
| Athanasios Anastasilakis, PhD | 424 General Military Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 424 General Military Hospital | Thessaloniki | 56429 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8654625 | Background | 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. | |
| 2526152 | Background | 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. |
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After study results being accepted for publication they will be available for everyone that might ask for them
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D017273 | Goserelin |
| D007987 | Gonadotropin-Releasing Hormone |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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serum samples
| between baseline and 6 months after goserelin discontinuation |
| sclerostin | bone metabolism parameter measured in sera | 0,6,12 months |
| periostin | bone metabolism parameter measured in sera | 0,3,6,12 months |
| irisin | myokine measured in sera | 0,3,6,12 months |
| follistatin | myokine measured in sera | 0,3,6,12 months |
| activin-A | myokine measured in sera | 0,3,6,12 months |
| noggin | BMP inhibitor measured in sera | 0,3,6,12 months |
| miRs | bone related microRNAs measured in sera | 0,6,12 months |
| 8604604 | Background | 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. |
| D000091662 | Genital Diseases |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |