Efficacy of vaginal danazol treatment in women with recurrent deeply infiltrating endometriosis
Open accessAbstract
Objective To describe a safe long-term medical treatment for deeply infiltrating endometriosis, a critical condition characterized by multiple painful symptoms and a high recurrence rate after surgical treatment.Design Prospective study.Setting University of Siena.Patient(s) Twenty-one women with deeply infiltrating endometriosis.Intervention(s) In a nonrandomized prospective study a low dose of vaginal danazol (200 mg/d) was self-administered for 12 months. After a previous laparoscopic surgery, these patients had reported recurrent severe dyspareunia, dysmenorrhea, and pelvic pain (in five cases also painful defecation).Main outcome measure(s) Before and every 3 months during the treatment a visual analogue pain scale was used. Transvaginal and transrectal ultrasound examinations were performed before and after 6 and 12 months of treatment. Adverse effects were registered, and serum concentration of cholesterol, triglycerides, aspartate aminotransferase, alanine aminotransferase, glycemia, protein S, protein C, antithrombin III, and homocysteine was evaluated before and after 12 months.Result(s) Dysmenorrhea, dyspareunia, and pelvic pain significantly decreased within 3 months and disappeared after 6 months of treatment, with a persistent effect during the 12 months of treatment. A relief of painful defecation was also shown. Ultrasound examination showed a reduction of the nodularity in the rectovaginal septum within 6 months. The medical treatment did not affect metabolic or thrombophilic parameters; few local vaginal adverse effects were reported.Conclusion(s) Vaginal danazol resulted in effective medical treatment for the various painful symptoms in women with recurrent deeply infiltrating endometriosis, and because of the lack of significant adverse effects it may be proposed as an alternative to repeated surgery.
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In patients with DIE, vaginal danazol significantly reduces painful symptoms, with fewer recurrences and decreased volume of endometriosis lesions.
“A significant reduction of painful symptoms in patients with DIE was observed, with less recurrences and a decreased volume of endometriosis lesions [223].”
From Hormonal treatments for endometriosis: The endocrine background (2022) · cites this paper as [223]
The Results (p. 1) report significant reductions in painful symptoms, and the Discussion (p. 3) says vaginal danazol reduced lesion size. The paper describes women whose symptoms had recurred after surgery, but it does not report that vaginal danazol led to fewer recurrences. (LLM, conf=0.88)
Experimental — accuracy not yet measuredDanazol-loaded intrauterine device and off-label vaginal danazol (200 mg/day) have good efficacy and better tolerability, particularly for women with deep infiltrating endometriosis (DIE) and rectovaginal endometriosis.
“Good efficacy and better tolerability has been reported with danazol-loaded intrauterine device [221] and with off-label vaginal administration (200 mg/day) [222, 223], particularly for women with DIE and rectovaginal endometriosis [224].”
From Hormonal treatments for endometriosis: The endocrine background (2022) · cites this paper as [223]
A TSEC containing BZA and conjugated estrogens decreased endometriotic lesion size in a mouse model.
“A tissue-selective estrogen complex (TSEC) containing BZA and conjugated estrogens (CE) also decreased endometriotic lesion size in a mouse model.”
From Hormonal treatments for endometriosis: The endocrine background (2022) · cites this paper as [223]
Materials and Methods (p. 2) describes a study of vaginal danazol in women, and the Discussion (p. 3) reports reduced lesion size with that treatment. Searches for BZA, conjugated estrogens, and a mouse model found no passage addressing the claimed TSEC result; the danazol finding neither supports nor contradicts it. (LLM, conf=0.76)
Experimental — accuracy not yet measuredAdding estrogens to BZA did not induce endometrial growth or hyperplasia and did not reduce SERM efficacy.
“The addition of estrogens to BZA did not induce endometrial growth or endometrial hyperplasia and did not reduce the efficacy of the SERM [223].”
From Hormonal treatments for endometriosis: The endocrine background (2022) · cites this paper as [223]
The treatment description (p. 2) identifies vaginal danazol, not BZA, as the drug studied. The discussion (p. 5) says low-dose danazol did not modify endometrial thickness, but it does not address adding estrogens to BZA, endometrial hyperplasia, or SERM efficacy. Searches for BZA, bazedoxifene, and those outcomes found no passage supporting the attributed claim. (LLM, conf=0.78)
Experimental — accuracy not yet measured
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- Authors
- Razzi, S., Luisi, S., Calonaci, F., Altomare, A., Bocchi, C., & Petraglia, F.
- Affiliations
- University of Siena (IT)
- Corresponding author
- Petraglia, Felice
- Venue
- Fertility and Sterility
- Publisher
- Elsevier BV
- Published
- 2007-10
- Volume
- 88
- Issue
- 4
- Pages
- 789-794
- ISSN
- 0015-0282 (ISSN-L)
- OpenAlex
- W2159777458
- Cited by
- 100
- References
- 26
- Citations by year
- 2026: 4 · 2025: 6 · 2024: 4 · 2023: 3 · 2022: 6 · 2021: 4 · 2020: 8 · 2019: 3 · 2018: 3 · 2017: 8 · 2016: 3 · 2015: 8 · 2014: 4 · 2013: 4 · 2012: 5
- FWCI
- 5.53
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Fertility and Sterility (publishedVersion)
- PubMed (publishedVersion)
- CINECA IRIS Institutial research information system (University of Pisa) (submittedVersion)
- Florence Research (University of Florence) (submittedVersion)
- Use Siena air (University of Siena) (submittedVersion)
- Topics
- Health Sciences › Medicine › Reproductive Medicine › Endometriosis Research and Treatment
- Health Sciences › Medicine › Obstetrics and Gynecology › Gynecological conditions and treatments
- Health Sciences › Medicine › Obstetrics and Gynecology › Endometrial and Cervical Cancer Treatments
- Keywords
- deep infiltrating endometriosis, recurrent endometriosis, dysmenorrhea, dyspareunia, pelvic pain, painful defecation, thrombophilia
- MeSH terms
- Administration, Intravaginal, Adult, Danazol, Endometriosis, Female, Humans, Prospective Studies, Recurrence
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