Cited by 127Endometriosis Research and TreatmentEctopic Pregnancy Diagnosis and ManagementMenstrual Health and Disorders

Norethindrone acetate or dienogest for the treatment of symptomatic endometriosis: a before and after study

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Vercellini, Paolo, Bracco, Benedetta, Mosconi, Paola, Roberto, Anna, Alberico, Daniela, Dhouha, Dridi, Somigliana, Edgardo·2016·Fertility and Sterility

Abstract

Objective To assess the proportion of patients satisfied with their treatment before and after a systematic change from norethindrone acetate to dienogest as the first-line progestin for symptomatic endometriosis.Design Before and after study.Setting Academic department.Patient(s) The last 90 new consecutive endometriosis patients in whom norethindrone acetate was used, and the first 90 new consecutive endometriosis patients in whom dienogest was used.Intervention(s) Norethindrone acetate at the oral dose of 2.5 mg once a day until June 6, 2013, then dienogest at the oral dose of 2 mg once a day thereafter.Main outcome measure(s) Degree of satisfaction with treatment after 6 months of progestin therapy and assessment of any variations in pain symptoms, psychological status, sexual function, or health-related quality of life associated with the introduction of dienogest.Result(s) The proportion of satisfied plus very satisfied women after 6 months of treatment was 71% in the "before" period (norethindrone acetate) and 72% in the "after" period (dienogest). The implementation of dienogest was not associated with statistically significant ameliorations in overall pain relief, psychological status, sexual functioning, or health-related quality of life. Treatment was well tolerated by 58% of norethindrone acetate users compared with 80% of dienogest users. After dienogest implementation, the absolute risk reduction in the occurrence of any side effect was 13.9% (95% confidence interval, 0.8%-28.6%).Conclusion(s) Considering the large difference in the cost of the two drugs, dienogest should be suggested selectively in women who do not tolerate norethindrone acetate.

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Crossref · 10.1016/j.fertnstert.2015.11.016

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  • NETA has strong progestogenic and androgenic activity, which may cause side effects such as weight gain, acne, and seborrhea.

    “NETA has strong progestogenic effects and a androgenic activity, that may cause side effects due to its residual androgenic activity (weight gain, acne, and seborrhea) [208].”

    From Hormonal treatments for endometriosis: The endocrine background (2022) · cites this paper as [208]

    The Tolerability section (page unavailable) describes NETA’s progestogenic activity as “strongly effective” and its androgenic activity as “effective”; it says these properties may partly explain reported weight gain and acne. Table 3 also lists both effects in NETA users. Our copy does not mention seborrhea as a side effect, so that part of the attributed claim is unsupported. (LLM, conf=0.89)

    Experimental — accuracy not yet measured
  • In newly diagnosed endometriosis women, low-dose NETA was well tolerated by 58% of users compared with 80% of DNG users.

    “The comparison between low dose NETA and DNG as first line drug used in new diagnosed endometriosis women showed that treatment was well tolerated by 58% of NETA users compared with 80% of DNG users [208].”

    From Hormonal treatments for endometriosis: The endocrine background (2022) · cites this paper as [208]

    The Tolerability section reports that 58% of norethindrone acetate users and 80% of dienogest users rated treatment well or very well tolerated; the Treatments section gives the norethindrone acetate dose as 2.5 mg daily. However, the Results section says these patients were new to the clinics, not necessarily newly diagnosed: 69% had previously undergone surgery for endometriosis. (LLM, conf=0.90)

    Experimental — accuracy not yet measured
  • In a study comparing NETA and dienogest, 70% and 72% of patients respectively were very satisfied or satisfied, meaning around 30% were dissatisfied, 10% very dissatisfied.

    “A study comparing NETA and dienogest [83] reported that 70% and 72% of patients, respectively, were very satisfied or satisfied, meaning that a substantial proportion, around 30% of women, were left dissatisfied, 10% of whom were very dissatisfied.”
  • Menstrual pain (dysmenorrhea) was almost eradicated in both NETA and dienogest groups as a result of amenorrhea induced by the two progestins.

    “It was noted that menstrual pain (dysmenorrhea) was almost eradicated in both groups as a result of amenorrhea induced by the two progestins [83].”
  • Efficacy of NETA and dienogest was similar in terms of pain reduction (dysmenorrhea, dyspareunia, non-menstrual pelvic pain).

    “Efficacy was similar in terms of pain reduction (dysmenorrhea, dyspareunia, non-menstrual pelvic pain).”

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Authors
Vercellini, P., Bracco, B., Mosconi, P., Roberto, A., Alberico, D., Dhouha, D., & Somigliana, E.
Affiliations
  • University of Milan (IT)
  • Mario Negri Institute for Pharmacological Research (IT)
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IT)
Corresponding author
Vercellini, Paolo
Venue
Fertility and Sterility
Publisher
Elsevier BV
Published
2016-03
Volume
105
Issue
3
Pages
734-743.e3
ISSN
0015-0282 (ISSN-L)
OpenAlex
W2190711277
Cited by
127
References
56
Citations by year
2026: 6 · 2025: 10 · 2024: 4 · 2023: 12 · 2022: 15 · 2021: 11 · 2020: 19 · 2019: 6 · 2018: 18 · 2017: 19 · 2016: 7
FWCI
16.75
Type
journal article
Language
en
Open access
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 › Public Health, Environmental and Occupational Health › Menstrual Health and Disorders
Keywords
endometriosis, norethindrone acetate, dienogest, progestin therapy, treatment satisfaction, analgesia, health-related quality of life, sexual function, psychological state, drug tolerability, adverse effects, cost comparison
MeSH terms
Norethindrone Acetate, Adult, Cost-Benefit Analysis, Endometriosis, Female, Humans, Nandrolone, Norethindrone, Progestins, Quality of Life, Drug Costs, Treatment Outcome, Patient Satisfaction, Drug Substitution

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