Anastrozole and levonorgrestrel-releasing intrauterine device in the treatment of endometriosis: a randomized clinical trial

Abstract Background To study the effectiveness of an aromatase inhibitor (Anastrozole) associated with levonorgestrel-releasing intrauterine device (LNG-IUD, Mirena®) in the treatment of endometriosis. Methods Prospective, randomized clinical trial. Setting: University Hospital (single center). Elegibility criteria: Endometriomas > 3 × 4 cm, CA-125 > 35 U/mL and endometriosis symptoms. Patients: Thirty-one women randomized to anastrozole + Mirena® + Conservative Surgery(CS) (n = 8), anastrozole + Mirena® + transvaginal ultrasound-guided puncture-aspiration (TUGPA) (n = 7), Mirena® + CS (n = 9), or Mirena® + TUGPA (n = 7). Interventions: Anastrozole 1 mg/day and/or only Mirena® for 6 months; CS (ovarian and fertility-sparing) or TUGPA of endometriomas one month after starting medical treatment. Main Outcome Measures: Visual analogic scale for symptoms, CA-125 levels, ultrasound findings of endometriomas and recurrences. Results A significant improvement in symptoms during the treatment (difference of 43%, 95% CI 29.9–56.2) occurred, which was maintained at 1 and 2 years. It was more significant in patients including anastrozole in their treatment (51%, 95% CI 33.3–68.7). For CA-125, the most significant decrease was observed in patients not taking anastrozole (73.8%, 95% CI 64.2–83.4 vs. 53.8%, 95% CI 25.7–81.6 under Mirena® + anastrozole). After CS for endometriosis, a reduction of ultrasound findings of endometriomas and long-term recurrence occurred, with or without anastrozole. At 4.2 ± 1.7 years (95% CI 3.57–4.85), 88% of the patients who underwent CS were asymptomatic, without medication or reoperation, compared to only 21% if TUGPA was performed, with or without anastrozole (p = 0.019). Conclusions Dosing anastrozole for 6 months, starting one month before CS of endometriosis, reduces significantly the painful symptoms and delays recurrence, but has no other significant advantages over the single insertion of LNG-IUD (Mirena®) during the same time. Anastrozole and/or only Mirena® associated with TUGPA are not effective. Trial registration Eudra CT System of the European Medicines Agency (London, 29-Sept-2008) Nº EudraCT: 2008-005744-17 (07/11/2008). Date of enrolment of first patient: 15/01/2009.

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Anastrozole and Levonorgrestrel-Releasing Intrauterine Device in the Treatment of Endometriosis: A Randomized Clinical Trial.

10.21203/rs.3.rs-51837/v2 ◽

2020 ◽

Author(s):

Pedro Acién ◽

Irene Velasco ◽

Maribel Acién

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Transvaginal Ultrasound ◽

Intrauterine Device ◽

Conservative Surgery ◽

University Hospital ◽

Ca 125 ◽

European Medicines Agency ◽

Fertility Sparing ◽

Ultrasound Guided Puncture

Abstract Background: To study the effectiveness of an aromatase inhibitor (Anastrozole) associated to levonorgestrel-releasing intrauterine device (LNG-IUD, Mirena®) in the treatment of endometriosis.Methods: Prospective, randomized clinical trial. Setting: University Hospital (single center). Elegibility criteria: Endometriomas >3×4 cm, CA-125>35 U/mL and endometriosis symptoms. Patients: Thirty-one women randomized to anastrozole+Mirena®+Conservative Surgery(CS) (n=8), anastrozole+Mirena®+transvaginal ultrasound-guided puncture-aspiration (TUGPA) (n=7), Mirena®+CS (n=9), or Mirena®+TUGPA (n=7). Interventions: Anastrozole 1 mg/day and/or only Mirena® for 6 months; CS (ovarian and fertility-sparing) or TUGPA of endometriomas one month after starting medical treatment. Main Outcome Measures: Visual analogic scale for symptoms, CA-125 levels, ultrasound findings of endometriomas and recurrences.Results: A significant improvement in symptoms during the treatment (difference of 43%, 95% CI 29.9-56.2) occurred, which was maintained at 1 and 2 years. It was more significant in patients treated with anastrozole (51%, 95% CI 33.3-68.7). For CA-125, the most significant decrease was observed without anastrozole (73.8%, 95% CI 64.2-83.4 vs. 53.8%, 95% CI 25.7-81.6 under Mirena®+anastrozole). After CS for endometriosis, a reduction of findings of endometriomas and long-term recurrences occurred, with or without anastrozole. At 4,2±1,7 years (95% CI 3,57-4,85), 88% of the patients who underwent CS were asymptomatic, without medication or reoperation, compared to only 21% if TUGPA was performed, with or without anastrozole (p=0.019).Conclusions: Dosing anastrozole for 6 months, starting one month before CS of endometriosis, reduces more significantly the painful symptoms and delays recurrences, but has no other significant advantages over the single insertion of LNG-IUD (Mirena®) during the same time. Anastrozole and/or only Mirena® associated with TUGPA are not effective.Details of trial registration: Eudra CT System of the European Medicines Agency (London, 29-Sept-2008) Nº EudraCT: 2008-005744-17 (07/11/2008). Date of enrolment of first patient: 15/01/2009.

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Anastrozole and Levonorgrestrel-Releasing Intrauterine Device in the Treatment of Endometriosis: A Randomized Clinical Trial.

10.21203/rs.3.rs-51837/v1 ◽

2020 ◽

Author(s):

Pedro Acién ◽

Irene Velasco ◽

Maribel Acién

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Transvaginal Ultrasound ◽

Intrauterine Device ◽

Conservative Surgery ◽

University Hospital ◽

Ca 125 ◽

European Medicines Agency ◽

Fertility Sparing ◽

Ultrasound Guided Puncture

Abstract Background: To study the effectiveness of an aromatase inhibitor (Anastrozole) associated to levonorgestrel-releasing intrauterine device (LNG-IUD, Mirena®) in the treatment of endometriosis.Methods: Prospective, randomized clinical trial. Setting: University Hospital (single center). Elegibility criteria: Endometriomas >3×4 cm, CA-125>35 U/mL and endometriosis symptoms. Patients: Thirty-one women randomized to anastrozole+Mirena®+Conservative Surgery(CS) (n=8), anastrozole+Mirena®+transvaginal ultrasound-guided puncture-aspiration (TUGPA) (n=7), Mirena®+CS (n=9), or Mirena®+TUGPA (n=7). Interventions: Anastrozole 1 mg/day and/or only Mirena® for 6 months; CS (ovarian and fertility-sparing) or TUGPA of endometriomas one month after starting medical treatment. Main Outcome Measures: Visual analogic scale for symptoms, CA-125 levels, ultrasound findings of endometriomas and recurrences.Results: A significant improvement in symptoms during the treatment (difference of 43%, 95% CI 29.9-56.2) occurred, which was maintained at 1 and 2 years. It was more significant in patients treated with anastrozole (51%, 95% CI 33.3-68.7). For CA-125, the most significant decrease was observed without anastrozole (73.8%, 95% CI 64.2-83.4 vs. 53.8%, 95% CI 25.7-81.6 under Mirena®+anastrozole). After CS for endometriosis, a reduction of findings of endometriomas and long-term recurrences occurred, with or without anastrozole. At 4,2±1,7 years (95% CI 3,57-4,85), 88% of the patients who underwent CS were asymptomatic, without medication or reoperation, compared to only 21% if TUGPA was performed, with or without anastrozole (p=0.019).Conclusions: Dosing anastrozole for 6 months, starting one month before CS of endometriosis, reduces more significantly the painful symptoms and delays recurrences, but has no other significant advantages over the single insertion of LNG-IUD (Mirena®) during the same time.Details of trial registration: Eudra CT System of the European Medicines Agency (London, 29-Sept-2008) Nº EudraCT: 2008-005744-17 (07/11/2008). Date of enrolment of first patient: 15/01/2009.

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Anastrozole and Levonorgrestrel-Releasing Intrauterine Device in the Treatment of Endometriosis: A Randomized Clinical Trial.

10.21203/rs.3.rs-51837/v4 ◽

2020 ◽

Author(s):

Pedro Acién ◽

Irene Velasco ◽

Maribel Acién

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Transvaginal Ultrasound ◽

Intrauterine Device ◽

Conservative Surgery ◽

University Hospital ◽

Ca 125 ◽

Fertility Sparing ◽

Ultrasound Guided Puncture ◽

Guided Puncture

Abstract Background: To study the effectiveness of an aromatase inhibitor (Anastrozole) associated to levonorgestrel-releasing intrauterine device (LNG-IUD, Mirena®) in the treatment of endometriosis.Methods: Prospective, randomized clinical trial. Setting: University Hospital (single center). Elegibility criteria: Endometriomas >3×4 cm, CA-125>35 U/mL and endometriosis symptoms. Patients: Thirty-one women randomized to anastrozole+Mirena®+Conservative Surgery(CS) (n=8), anastrozole+Mirena®+transvaginal ultrasound-guided puncture-aspiration (TUGPA) (n=7), Mirena®+CS (n=9), or Mirena®+TUGPA (n=7). Interventions: Anastrozole 1 mg/day and/or only Mirena® for 6 months; CS (ovarian and fertility-sparing) or TUGPA of endometriomas one month after starting medical treatment. Main Outcome Measures: Visual analogic scale for symptoms, CA-125 levels, ultrasound findings of endometriomas and recurrences. Results: A significant improvement in symptoms during the treatment (difference of 43%, 95% CI 29.9-56.2) occurred, which was maintained at 1 and 2 years. It was more significant in patients treated with anastrozole (51%, 95% CI 33.3-68.7). For CA-125, the most significant decrease was observed without anastrozole (73.8%, 95% CI 64.2-83.4 vs. 53.8%, 95% CI 25.7-81.6 under Mirena®+anastrozole). After CS for endometriosis, a reduction of findings of endometriomas and long-term recurrences occurred, with or without anastrozole. At 4,2±1,7 years (95% CI 3,57-4,85), 88% of the patients who underwent CS were asymptomatic, without medication or reoperation, compared to only 21% if TUGPA was performed, with or without anastrozole (p=0.019). Conclusions: Dosing anastrozole for 6 months, starting one month before CS of endometriosis, reduces more significantly the painful symptoms and delays recurrences, but has no other significant advantages over the single insertion of LNG-IUD (Mirena®) during the same time. Anastrozole and/or only Mirena® associated with TUGPA are not effective.

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Anastrozole and Levonorgrestrel-Releasing Intrauterine Device in the Treatment of Endometriosis: A Randomized Clinical Trial.

10.21203/rs.3.rs-51837/v3 ◽

2020 ◽

Author(s):

Pedro Acién ◽

Irene Velasco ◽

Maribel Acién

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Transvaginal Ultrasound ◽

Intrauterine Device ◽

Conservative Surgery ◽

University Hospital ◽

Ca 125 ◽

Fertility Sparing ◽

Ultrasound Guided Puncture ◽

Guided Puncture

Abstract Background: To study the effectiveness of an aromatase inhibitor (Anastrozole) associated to levonorgestrel-releasing intrauterine device (LNG-IUD, Mirena®) in the treatment of endometriosis.Methods: Prospective, randomized clinical trial. Setting: University Hospital (single center). Elegibility criteria: Endometriomas >3×4 cm, CA-125>35 U/mL and endometriosis symptoms. Patients: Thirty-one women randomized to anastrozole+Mirena®+Conservative Surgery(CS) (n=8), anastrozole+Mirena®+transvaginal ultrasound-guided puncture-aspiration (TUGPA) (n=7), Mirena®+CS (n=9), or Mirena®+TUGPA (n=7). Interventions: Anastrozole 1 mg/day and/or only Mirena® for 6 months; CS (ovarian and fertility-sparing) or TUGPA of endometriomas one month after starting medical treatment. Main Outcome Measures: Visual analogic scale for symptoms, CA-125 levels, ultrasound findings of endometriomas and recurrences. Results: A significant improvement in symptoms during the treatment (difference of 43%, 95% CI 29.9-56.2) occurred, which was maintained at 1 and 2 years. It was more significant in patients treated with anastrozole (51%, 95% CI 33.3-68.7). For CA-125, the most significant decrease was observed without anastrozole (73.8%, 95% CI 64.2-83.4 vs. 53.8%, 95% CI 25.7-81.6 under Mirena®+anastrozole). After CS for endometriosis, a reduction of findings of endometriomas and long-term recurrences occurred, with or without anastrozole. At 4,2±1,7 years (95% CI 3,57-4,85), 88% of the patients who underwent CS were asymptomatic, without medication or reoperation, compared to only 21% if TUGPA was performed, with or without anastrozole (p=0.019). Conclusions: Dosing anastrozole for 6 months, starting one month before CS of endometriosis, reduces more significantly the painful symptoms and delays recurrences, but has no other significant advantages over the single insertion of LNG-IUD (Mirena®) during the same time. Anastrozole and/or only Mirena® associated with TUGPA are not effective.

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Anastrozole and Levonorgrestrel-Releasing Intrauterine Device in the Treatment of Endometriosis: A Randomized Clinical Trial

10.20944/preprints201911.0010.v1 ◽

2019 ◽

Author(s):

Pedro Acién ◽

Irene Velasco ◽

Maribel Acién

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Transvaginal Ultrasound ◽

Intrauterine Device ◽

Conservative Surgery ◽

Ca 125 ◽

Ultrasound Guided Puncture ◽

Guided Puncture ◽

Single Insertion

Background: Effectiveness of Anastrozole and levonorgestrel-releasing intrauterine device (LNG-IUD, Mirena®) in the treatment of endometriosis. Methods: Randomized clinical trial. Elegibility criteria: Endometriomas >3×4 cm, CA-125>35 U/mL and symptoms suggestive of endometriosis. Thirty-one women were randomized to anastrozole+Mirena®+Conservative Surgery(CS) (n=8), anastrozole+Mirena®+transvaginal ultrasound-guided puncture-aspiration(TUGPA) (n=7), Mirena®+CS (n=9), or Mirena®+TUGPA (n=7). Interventions: Anastrozole 1 mg/day and/or only Mirena® for 6 months. CS or TUGPA one month after starting medical treatment. Results: A significant improvement in symptoms during the treatment (difference of 43%, 95% CI 29.9-56.2) occurred, which was maintained at 1 and 2 years. It was more significant in patients treated with anastrozole. For CA-125, the most significant decrease was observed without anastrozole. After CS for endometriosis, a reduction of findings of endometriomas and long-term recurrences occurred, with or without anastrozole, although anastrozole seems to delay recurrences. At 4,2±1,7 years, 88% of the patients who underwent CS were asymptomatic, compared to only 21% if TUGPA was performed, with or without anastrozole (p=0.019). Conclusion: Dosing anastrozole for 6 months, starting one month before CS of endometriosis, reduces more significantly the painful symptoms and delays recurrences, but has no other significant advantages over the single insertion of LNG-IUD (Mirena®) during the same time.

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Oral diclofenac potassium versus hyoscine-N-butyl bromide for pain relief during copper intrauterine device insertion: randomized clinical trial

International Journal of Reproduction Contraception Obstetrics and Gynecology ◽

10.18203/2320-1770.ijrcog20180855 ◽

2018 ◽

Vol 7 (3) ◽

pp. 783

Author(s):

Ahmed M. Abbas ◽

Mohammed F. Abdel-Ghany ◽

Nadia Abdullah Mohammed ◽

Mostafa Khodry ◽

Armia Michael ◽

...

Keyword(s):

Clinical Trial ◽

Pain Relief ◽

Randomized Clinical Trial ◽

Pain Perception ◽

Intrauterine Device ◽

Study Groups ◽

University Hospital ◽

Butyl Bromide ◽

Copper Iud ◽

Copper Intrauterine Device

Background: Present study was carried out to compare the analgesic effect of oral diclofenac potassium versus hyoscine-N-butyl bromide (HBB) for pain relief during copper intrauterine device (IUD) insertion.Methods: It was a a randomized clinical trial carried out at Assiut University Hospital, Assiut, Egypt. Parous women eligible for Copper IUD insertion were recruited and randomized in a 1:1 ratio to diclofenac potassium or HBB. The participants were asked to take 2 tablets of the study medications 30 minutes before IUD insertion. The primary outcome was the participant's self-rated pain perception using a 10-cm Visual Analogue Scale (VAS) during IUD insertion. We considered a 1.5 cm difference in VAS scores between study groups as clinically significant.Results: One hundred eight women were enrolled (n=54 in each group). Diclofenac significantly has lower mean pain score during speculum placement (1.73 vs. 2.13) and tenaculum placement (1.85 vs. 2.3) than HBB with p<0.001. No statistical significant differences between both groups in other steps of IUD insertion. Additionally, the duration of IUD insertion was significantly lower in the diclofenac group (5.34±0.76 vs. 5.74±1.23 minutes, p=0.045). No women reported side effects in both groups.Conclusions: The use of oral diclofenac potassium 30 minutes prior to copper IUD insertion slightly reduce the insertional pain and duration than oral HBB with no adverse effects.

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Endometrial osseous metaplasia: Presentation of two rare cases related with infertility, and their hysteroscopic approaching

International Archives of Medicine ◽

10.3823/2505 ◽

2017 ◽

Vol 10 ◽

Author(s):

José Martínez-Más ◽

Paloma Gómez-Leal ◽

Juan Pedro Martínez-Cendán ◽

Andrés Bueno-Crespo ◽

Sebastián Ortiz-Reina ◽

...

Keyword(s):

Therapeutic Option ◽

Transvaginal Ultrasound ◽

Intrauterine Device ◽

Ultrasound Image ◽

University Hospital ◽

Osseous Metaplasia ◽

Ultrasound Scan ◽

Hospital Patients ◽

Bone Fragments ◽

Diagnostic Hysteroscopy

Objective: To present two cases of patients diagnosed of endometrial osseous metaplasia related with infertility and their hysteroscopic approaching. Design: Case report. Setting: Two clinical cases diagnosed and treated at Institutional University Hospital. Patients: Two premenopasual women diagnosed and treated in our Center. Interventions: Transvaginal ultrasound scan, diagnostic hysteroscopy and hysteroscopic removal of bone fragments. Main Outcome Measures: Ultrasound scan during further clinical follow up. Results: Both patients underwent a diagnostic hysteroscopy, and removal of all the bone fragments with total resolution of their pathology. Conclusions: Endometrial osseous metaplasia is a rare pathology that should be suspected in patients with a history of secondary infertility, several miscarriages and curettages, that present with an ultrasound image compatible with an intrauterine device. Hysteroscopic approach is the best diagnostic and therapeutic option. Key words: Endometrial osseous metaplasia, bony intrauterine tissue, miscarriage, infertility, hysteroscopy, unadverted intrauterine device.

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A randomized clinical trial between ultrasound-guided and uterine sound-sparing approach for copper intrauterine device insertion

Fertility and Sterility ◽

10.1016/j.fertnstert.2019.07.159 ◽

2019 ◽

Vol 112 (3) ◽

pp. e9

Author(s):

Mohammed Khairy Ali ◽

Ahmed M. Abbas ◽

Asmaa Ramadan ◽

Ahmed M. Abdelmagied ◽

Mostafa Nasr Ibrahim ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Intrauterine Device ◽

Ultrasound Guided ◽

Copper Intrauterine Device

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Incidence of Decreased Hip Range of Motion in Youth Soccer Players and Response to a Stretching Program: A Randomized Clinical Trial

Journal of Sport Rehabilitation ◽

10.1123/jsr.22.2.100 ◽

2013 ◽

Vol 22 (2) ◽

pp. 100-107 ◽

Cited By ~ 9

Author(s):

Jacqueline Vieira de Castro ◽

Karina Costa Machado ◽

Kelly Scaramussa ◽

João Luiz Ellera Gomes

Keyword(s):

Clinical Trial ◽

Range Of Motion ◽

Randomized Clinical Trial ◽

Outcome Measures ◽

University Hospital ◽

Soccer Players ◽

Youth Soccer ◽

Wide Range ◽

Hip Rotation ◽

Stretching Exercises

Context:After years of focusing on the management of anterior cruciate ligament (ACL) injuries, the most common soccer-related injuries, the orthopedic community has concluded that soccer players have a wide range of variation in joint biomechanics and has thus started to focus research efforts on the morphological factors that might contribute to ACL trauma. One such factor is decreased hip-rotation range of motion (ROM), which may be due to compensatory musculoskeletal changes occurring in response to longstanding soccer practice since childhood.Objective:This study sought to assess decreased hip rotation and the influence of stretching exercises on the behavior of the hip joint in players of the youth soccer categories of a Brazilian soccer team.Design:Randomized clinical trial.Setting:University hospital.Patients:262 male soccer players.Interventions:Subjects were randomly allocated into 2 groups—control or a stretching program.Main Outcome Measures:Subjects were reassessed after 12 wk.Results:The findings suggest that hip-rotation ROM decreases over the years in soccer players. In the study sample, adherence to a stretching program improved only external hip-rotation ROM in the nondominant limb.Conclusion:Playing soccer can restrict rotation ROM of the hip, and adherence to stretching exercises may decrease the harmful effects on the hip joints.

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