Subcutaneous injection of depot medroxyprogesterone acetate compared with leuprolide acetate in the treatment of endometriosis-associated pain
Open accessAbstract
Objective To compare the efficacy and safety of SC depot medroxyprogesterone acetate (DMPA-SC 104) with that of leuprolide acetate in treatment of endometriosis.Design Phase 3, multicenter, randomized, evaluator-blinded, comparator-controlled trial.Setting Clinical trial sites in Canada and United States.Patient(s) Two hundred seventy-four women with surgically diagnosed endometriosis.Intervention(s) Intramuscular injections of DMPA-SC (104 mg) or leuprolide acetate (11.25 mg), given every 3 months for 6 months, with 12 months of posttreatment follow-up.Main outcome measure(s) Reduction in five endometriosis symptoms or signs (dysmenorrhea, dyspareunia, pelvic pain, pelvic tenderness, pelvic induration); change in bone mineral density (BMD), hypoestrogenic symptoms, bleeding, and weight.Result(s) The depot medroxyprogesterone acetate given SC was statistically equivalent to leuprolide in reducing four of five endometriosis symptoms or signs at the end of treatment (month 6) and in reducing all five symptoms after 12 months' follow-up (month 18). Patients in the DMPA-SC 104 group showed significantly less BMD loss than did leuprolide patients at month 6, with scores returning to baseline at 12 months' follow-up. No statistically significant differences in median weight changes were observed between groups. Compared with leuprolide, DMPA-SC 104 was associated with fewer hypoestrogenic symptoms but more irregular bleeding.Conclusion(s) Efficacy of DMPA-SC 104 was equivalent to that of leuprolide for reducing endometriosis-associated pain, with less impact on BMD and fewer hypoestrogenic side effects but more bleeding.
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Depot medroxyprogesterone acetate has demonstrated efficacy equivalent to leuprolide acetate, but long-term use impacts adversely on bone mineral density, and the delay in resumption of ovulation that may follow discontinuation is a contraindication in women wishing to conceive in the near future.
“Depot medroxyprogesterone acetate (MPA; 104 mg, subcutaneous injection, every 3 months) has demonstrated an efficacy equivalent to LA, but long-term use of depot MPA preparations is shown to impact adversely on bone mineral density (BMD), while the delay in resumption of ovulation that may follow discontinuation of this therapy is a contraindication to use in women wishing to conceive in the near”
From Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial (2010) · cites this paper as Schlaff et al., 2006
Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredMPA is as effective as GnRH agonists in reducing endometriosis-related pain.
“MPA appeared to be more effective than placebo [214] and as effective as danazol [215] and GnRH-agonists [216, 217] in reducing endometriosis-related pain.”
From Hormonal treatments for endometriosis: The endocrine background (2022) · cites this paper as [217]
Irregular uterine bleeding is a known adverse effect of treatment with progestins, including depot preparations of MPA, which have been compared in trials against LA.
“Irregular uterine bleeding is a known adverse effect of treatment with progestins, including depot preparations of MPA, which have been compared in trials against LA (Vercellini et al., 2003;Crosignani et al., 2006;Schlaff et al., 2006).”
From Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial (2010) · cites this paper as Schlaff et al., 2006
In two large multicenter evaluator-blinded comparator-controlled trials, subcutaneous DMPA 104 mg/0.65 ml was statistically equivalent to leuprolide acetate in reducing pain symptoms after 12 months' follow-up.
“In both studies DMPA-SC was statistically equivalent to GnRHa in reducing pain symptoms after 12 months' follow-up.”
From Oral and depot progestin therapy for endometriosis: towards a personalized medicine (2017) · cites this paper as [51]
In those trials, DMPA-SC group showed significantly less BMD loss than leuprolide at month 6, and BMD returned to pretreatment levels at 12 months in DMPA-SC group but not leuprolide group.
“Patients in the DMPA-SC group showed significantly less BMD loss than did leuprolide patients at month 6.”
From Oral and depot progestin therapy for endometriosis: towards a personalized medicine (2017) · cites this paper as [51]
Progestins are positively associated with health-related quality of life in women with endometriosis.
“Progestins were positively associated with HRQoL in women with endometriosis [20,21,23-25,27,29,30].”
From Health-related quality of life in women with endometriosis: a systematic review (2012) · cites this paper as [25]
Six months of GnRHa treatment improves women's health-related quality of life even at one year after treatment.
“Six months of GnRHa treatment improved women’s HRQoL even at one year after treatment, according to the SF-36 questionnaire [24-27,29], as well as work-related indexes [18,20].”
From Health-related quality of life in women with endometriosis: a systematic review (2012) · cites this paper as [25]
Six months of progestin therapy is equivalent to GnRHa in improving health-related quality of life and reducing pain in women with endometriosis.
“Moreover, six months of therapy with progestins seemed equivalent to that of GnRHa in improving HRQoL and reducing pain, according to six RCTs [20,23-25,27,29].”
From Health-related quality of life in women with endometriosis: a systematic review (2012) · cites this paper as [25]
Subcutaneous depomedroxyprogesterone acetate (104 mg/0.65 mL) improves all pre-specified scales of the EHP-30 and SF-36 from baseline to the end of 6-month treatment and at 18-month follow-up.
“Subcutaneous injections of depomedroxyprogesterone acetate (104 mg/0.65 mL) improved all pre-specified scales of the EHP-30 and SF-36 from baseline to the end of the 6-month treatment and even at the 18-month follow-up [24,25].”
From Health-related quality of life in women with endometriosis: a systematic review (2012) · cites this paper as [25]
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- Authors
- Schlaff, W. D., Carson, S. A., Luciano, A., Ross, D., & Bergqvist, A.
- Affiliations
- University of Colorado Health (US)
- Baylor College of Medicine (US)
- University of Connecticut (US)
- Pfizer (United States) (US)
- Karolinska Institutet (SE)
- Corresponding author
- Schlaff, William D.
- ORCID
- Luciano, Anthony
- Venue
- Fertility and Sterility
- Publisher
- Elsevier BV
- Published
- 2006-02
- Volume
- 85
- Issue
- 2
- Pages
- 314-325
- ISSN
- 0015-0282 (ISSN-L)
- OpenAlex
- W2017780870
- Semantic Scholar
- e24478c88204964afa49b33817b516679f38a0a8
- Cited by
- 168
- References
- 28
- Citations by year
- 2026: 8 · 2025: 3 · 2024: 6 · 2023: 4 · 2022: 1 · 2021: 4 · 2020: 6 · 2019: 9 · 2018: 11 · 2017: 8 · 2016: 4 · 2015: 14 · 2014: 7 · 2013: 13 · 2012: 11
- FWCI
- 10.94
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Fertility and Sterility (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Pfizer
- 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 › Reproductive Health and Contraception
- Keywords
- endometriosis, endometriosis-associated pain, depot medroxyprogesterone acetate, leuprolide, GnRH agonist, GnRH antagonist, subcutaneous injection, bone mineral density, dysmenorrhea, dyspareunia, pelvic pain, irregular bleeding, weight change
- MeSH terms
- Adult, Delayed-Action Preparations, Endometriosis, Estrogens, Female, Flushing, Humans, Injections, Subcutaneous, Pain, Palliative Care, Quality of Life, Uterine Hemorrhage, Bone Density, Single-Blind Method, Leuprolide, Treatment Outcome, Medroxyprogesterone Acetate
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