BACKGROUND AND PURPOSE:

• Carvalho et al. (Fertility & Sterility, 2018) compared the efficacy of an etonogestrel (ENG)-releasing contraceptive implant and the 52-mg levonorgestrel-releasing intrauterine system (LNG-IUS) to treat endometriosis-associated pelvic pain

METHODS:

• Noninferiority randomized clinical trial
• Participants
  • Surgically and histologically confirmed diagnosis of stage I–IV endometriosis or diagnosis of deep endometriosis based on transvaginal ultrasonography and MRI
  • Complaints of noncyclic chronic pelvic pain and/or dysmenorrhea >6 months
• Study period: 180 Days
• Randomized to
  • Experimental treatment: ENG implant (Implanon NXT)
  • Active comparator: LNG-IUS (Mirena)
• Monthly follow-up visits up to 6 months
  • Daily scores of noncyclic pelvic pain and dysmenorrhea were evaluated using a daily visual analogue scale
    • VAS scale: From 0 (no pain) to 10cm (the worst pain imaginable)
  • Health-related quality of life was evaluated using the Endometriosis Health Profile-30 questionnaire at baseline and up to 6 months
• Bleeding patterns were assessed daily using a menstrual calendar
• Primary outcomes: Change in endometriosis-associated
  • Noncyclic pelvic pain
  • Dysmenorrhea
• Secondary outcomes
  • Health related quality of life | Bleeding patterns | Adverse Events
• Statistics: A minimum sample size of 45 women per study arm to achieve noninferiority
  • 0.05 significance level | Power of 0.80

RESULTS:

• 52 in ENG group | 51 in LNG-IUS group
• No significant difference between treatments for noncyclic pelvic pain and dysmenorrhea

Both contraceptives significantly improved the mean visual analogue scale endometriosis-associated pelvic pain and dysmenorrhea over 180 study days

• Noncyclic pelvic pain
  • ENG implant: Mean difference: 5.6 ± 1.7 (95% CI −6.4, −4.7)
  • IUD: Mean Difference: 5.5 ± 1.6; 95% CI −6.2, −4.4)
  • P<.0001 for both groups
• Dysmenorrhea
  • ENG implant: Mean difference: 5.3 ± 1.3 (95% CI −6.6, −4.3)
  • IUD: Mean difference: 5.4 ± 1.3 (95% CI −6.3, −4.3)
  • P<.0001 for both groups
• Health-related quality of life improved significantly in all domains for both groups
• Most common bleeding patterns at 180 days follow-up
  • ENG implant: Amenorrhea and infrequent bleeding
• LNG-IUS users: Infrequent bleeding and spotting

CONCLUSION:

• Both ENG and LNG-IUS result in improved pelvic pain, dysmenorrhea, and health-related quality of life in women with endometriosis

Learn More – Primary Sources:

Control of endometriosis-associated pain with etonogestrel-releasing contraceptive implant and 52-mg levonorgestrel-releasing intrauterine system: randomized clinical trial

Related ObG Topics:

Evaluation and Treatment of Endometriosis

Alleviation of Endometriosis Symptoms: Laparoscopic Excision or Ablation?

Does the Oral GnRH Antagonist Elagolix Improve Endometriosis-Associated Pain?