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Randomized Controlled Trial
. 2021 May 20;21(1):211.
doi: 10.1186/s12905-021-01347-9.

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

Pedro Acién  1   2   3 , Irene Velasco  4 , Maribel Acién  5   4
Affiliations
Randomized Controlled Trial

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

Pedro Acién et al. BMC Womens Health. .

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.

Keywords: Anastrozole; Aromatase inhibitors; Clinical trial; Endometriomas; Endometriosis; Levonorgestrel-IUD.

PubMed Disclaimer

Conflict of interest statement

We declare no competing interests. Not applicable.

Figures

Fig. 1
Fig. 1
Trial profile
Fig. 2
Fig. 2
Evolution of the symptoms score in patients taking or not Anastrozole: a VAS. b Dysmenorrhea. c Dyspareunia. d Chronic pelvic pain
Fig. 3
Fig. 3
Evolution of the variables of primary efficacy taking or not Anastrozole: a VAS, % improvement by treatment. b % of cases with CA-125 > 35 UI/mL. c Ultrasound finding (TVU) in the CT under Anastrozole (15 patients). d Ultrasound finding (TVU) in the CT, no Anastrozole (16 patients). Normal or dysfunctional = findings of normal ovaries or with dysfunctional cyst (luteal)
Fig. 4
Fig. 4
Accumulated % of recurrences and reoperations for Anastrozole versus no Anastrozole
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