Treatment of symptomatic rectovaginal endometriosis with an estrogen–progestogen combination versus low-dose norethindrone acetate
Open accessAbstract
Objective To evaluate the efficacy, safety, and tolerability of an estrogen-progestogen combination versus low-dose norethindrone acetate in the treatment of persistent pain after surgery for symptomatic rectovaginal endometriosis.Design Randomized controlled trial.Setting Academic center.Patient(s) Ninety women with recurrent moderate or severe pelvic pain after unsuccessful conservative surgery for symptomatic rectovaginal endometriosis.Intervention(s) Twelve-month, continuous treatment with oral ethinyl E2, 0.01 mg, plus cyproterone acetate, 3 mg/day, or norethindrone acetate, 2.5 mg/day.Main outcome measure(s) Degree of satisfaction with therapy.Result(s) Seven women in the ethinyl E2 plus cyproterone acetate arm and five in the norethindrone acetate arm withdrew because of side effects (n=5), treatment inefficacy (n=6), or loss to follow-up (n=1). At 12 months, dysmenorrhea, deep dyspareunia, nonmenstrual pelvic pain, and dyschezia scores were substantially reduced without major between-group differences. Both regimens induced minor unfavorable variations in the serum lipid profile. According to an intention-to-treat analysis, 28 (62%) out of 45 patients in the ethinyl E2 plus cyproterone acetate group and 33 (73%) out of 45 in the norethindrone acetate group were satisfied with the treatment received.Conclusion(s) Low-dose norethindrone acetate could be considered an effective, tolerable, and inexpensive first-choice medical alternative to repeat surgery for treating symptomatic rectovaginal endometriotic lesions in patients who do not seek conception.
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Low-dose oral NETA (2.5 mg/day) is effective, tolerable, and inexpensive as a first choice for symptomatic rectovaginal endometriosis, significantly decreasing VAS scores for dysmenorrhea and dyspareunia.
“Low-dose NETA 2.5 mg/day orally is considered an effective, tolerable and inexpensive first choice for symptomatic rectovaginal endometriosis, significantly decreasing VAS scores for dysmenorrhea and dyspareunia [209].”
From Hormonal treatments for endometriosis: The endocrine background (2022) · cites this paper as [209]
The Abstract describes oral norethindrone acetate (NETA) 2.5 mg/day as an effective, tolerable, inexpensive first-choice medical alternative to repeat surgery, but limits that conclusion to patients with symptomatic rectovaginal endometriosis who do not seek conception. The Results report statistically significant within-group reductions in visual analog scale pain scores, including dysmenorrhea and deep dyspareunia. The citing sentence omits the qualification on who the first-choice recommendation applies to. (LLM, conf=0.86)
Experimental — accuracy not yet measuredReported response rates for therapy with 2.5 mg norethindrone acetate per day in endometriosis-associated pain range between 74 and 92%.
“Reported response rates for therapy with 2.5 mg norethindrone acetate per day in endometriosis-associated pain range between 74 and 92%.”
From Pain and functional outcomes after surgical versus hormonal treatment in rectovaginal endometriosis: a retrospective cohort study (2026) · cites this paper as [29]
Evidence for hormonal treatment specifically in rectovaginal endometriosis is less abundant, and only one randomised-controlled trial was identified in the literature.
“Evidence for hormonal treatment specifically in RVE is less abundant and only one randomised-controlled trial was identified in the literature [29].”
From Pain and functional outcomes after surgical versus hormonal treatment in rectovaginal endometriosis: a retrospective cohort study (2026) · cites this paper as [29]
The proportion of endometriosis patients satisfied with OC treatment is ≥65%.
“Based on our previous experience, the proportion of endometriosis patients satisfied with OC treatment is $65% (20,57).”
From A stepped-care approach to symptomatic endometriosis management: A participatory research initiative (2018) · cites this paper as [20]
In a randomized trial of symptomatic rectovaginal endometriosis, NETA 2.5 mg/d and an EP combination were equally effective in managing pain symptoms and reducing lesion size at ultrasound.
“Both treatments were equally effective in the management of pain symptoms and on the reduction of lesion size at ultrasound.”
From Oral and depot progestin therapy for endometriosis: towards a personalized medicine (2017) · cites this paper as [13]
In that trial, 73% in NETA group were satisfied or very satisfied vs 62% in EP group.
“Overall, 73% women in the NETA group were satisfied or very satisfied with treatment compared to 62% in the EP group.”
From Oral and depot progestin therapy for endometriosis: towards a personalized medicine (2017) · cites this paper as [13]
Lower NETA dosage increases tolerability, reducing weight gain and androgenic side effects, and limits negative impact on serum cholesterol.
“The lower dosage increases the tolerability, reducing weight gain and androgenic side effects, and limits the negative impact on serum cholesterol values [13].”
From Oral and depot progestin therapy for endometriosis: towards a personalized medicine (2017) · cites this paper as [13]
Numerous studies demonstrated efficacy of a reduced daily NETA dose of 2.5 mg.
“numerous studies by independent groups demonstrated the efficacy of a reduced daily dose of 2.5 mg [13-16].”
From Oral and depot progestin therapy for endometriosis: towards a personalized medicine (2017) · cites this paper as [13]
In Italy, monthly cost of NETA 2.5 mg/d is less than 2 US$.
“in Italy, the monthly cost of treatment with 2.5 mg/d is less than 2 US $ [13].”
From Oral and depot progestin therapy for endometriosis: towards a personalized medicine (2017) · cites this paper as [13]
Low-dose oral NETA is probably the best choice for rectovaginal lesions.
“whereas low-dose oral NETA is probably the best choice for rectovaginal lesions”
From “Waiting for Godot”: a commonsense approach to the medical treatment of endometriosis (2011) · cites this paper as Vercellini et al., 2005
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Self-citation
- Authors
- Vercellini, P., Pietropaolo, G., De Giorgi, O., Pasin, R., Chiodini, A., & Crosignani, P. G.
- Affiliations
- University of Milan (IT)
- Corresponding author
- Vercellini, Paolo
- ORCID
- Vercellini, Paolo
- Venue
- Fertility and Sterility
- Publisher
- Elsevier BV
- Published
- 2005-11
- Volume
- 84
- Issue
- 5
- Pages
- 1375-1387
- ISSN
- 0015-0282 (ISSN-L)
- OpenAlex
- W2062896185
- Cited by
- 197
- References
- 28
- Citations by year
- 2026: 4 · 2025: 5 · 2024: 7 · 2023: 3 · 2022: 5 · 2021: 8 · 2020: 13 · 2019: 6 · 2018: 18 · 2017: 13 · 2016: 9 · 2015: 13 · 2014: 14 · 2013: 9 · 2012: 15
- FWCI
- 6.68
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Fertility and Sterility (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Reproductive Medicine › Endometriosis Research and Treatment
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ectopic Pregnancy Diagnosis and Management
- Health Sciences › Medicine › Obstetrics and Gynecology › Gynecological conditions and treatments
- Keywords
- rectovaginal endometriosis, norethindrone acetate, ethinyl estradiol, cyproterone acetate, dysmenorrhea, dyspareunia, dyschezia, treatment satisfaction, lipid profile
- MeSH terms
- Norethindrone Acetate, Adolescent, Adult, Drug Therapy, Combination, Endometriosis, Estrogens, Female, Humans, Middle Aged, Norethindrone, Pain Measurement, Progestins, Rectal Diseases, Vaginal Diseases, Estrogen Replacement Therapy, Confidence Intervals, Statistics, Nonparametric
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