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. 2023 Jun 21;2023(6):CD014788. doi: 10.1002/14651858.CD014788.pub2

Schlaff 2006.

Study characteristics
Methods Trial design: multi‐centre, randomised, evaluator‐blinded, comparator‐controlled trial
Participants Participants: 274 women were randomised; 190 women were analysed.
Mean age: medroxyprogesterone acetate group 29.2 ± 6.3 years, leuprolide group 32.1 ± 6.6 years
Inclusion criteria:
  • Premenopausal women

  • Age from 18 to 49 years

  • Persistent symptoms of pain caused by endometriosis (surgically diagnosed within previous 42 months)

  • Pain must have returned to its previous level within 30 days after a diagnostic laparoscopy or within 3 months after laparoscopy or laparotomy with surgical treatment and must have persisted for a minimum of 3 months.


Exclusion criteria: 
  • Baseline BMD at the lumbar spine and hip was < 1 SD below the peak adult bone mass


Setting: United States of America (43 sites) and Canada (7 sites)
Timing: not stated
Interventions Subcutaneous depot medroxyprogesterone acetate (DMPA) (104 mg/0.65 mL) every 3 months (n = 136) 
versus
Leuprolide (11.25 mg) intramuscular every 3 months (n = 138)
Outcomes
  • Bone Mineral Density

  • Pain (Biberoglu and Behrman symptom scale)

  • Quality of life

  • Adverse effects

  • Hypoestrogenic symptoms

  • Bleeding patterns

  • Endometriosis‐impact diary

Notes Intention‐to‐treat analysis: yes
Sample size calculation: yes
Funding: not stated
Author contacted; awaiting response
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Randomised". No further details of method used to generate the randomisation sequence were provided.
Allocation concealment (selection bias) Unclear risk "An independent person maintained the randomization code, received the study syringes, and administered the study medication".
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk No details provided of blinding of participants or personnel
Blinding of outcome assessment (detection bias)
All outcomes Low risk In this evaluator‐blinded study, the principal investigator and any designated sub‐investigators and study co‐ordinators at each centre were blinded to the randomisation of each participant.
Incomplete outcome data (attrition bias)
All outcomes High risk There was a dropout rate of 35.3% in the DMPA‐SC 104 group (48/136) and of 26.1% in the leuprolide group (36/138) during the 6‐month treatment period.
The majority of these participants either actively withdrew from the study (DMPA‐SC 104 = 21, leuprolide = 9) or were lost to follow‐up (14 and 11, respectively). Nine patients in each group (6.6% and 6.5% in the DMPA‐SC 104 and leuprolide groups, respectively) discontinued as a result of adverse side effects.
Of those women who completed the 6 months of active treatment, 51 (58.0%) of 88 in the DMPA‐SC 104 group and 58 (56.9%) of 102 in the leuprolide group left the study during the 12‐month follow‐up period.
Selective reporting (reporting bias) Low risk The study protocol was not available but it was clear that the published reports included all expected outcomes, including those that were prespecified.
Other bias Low risk No other risk of bias detected