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Dienogest Versus Leuprolide Acetate for Recurrent Pelvic Pain Following Laparoscopic Treatment of Endometriosis

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Abstract

Objective

To compare the efficacy and safety of dienogest (DNG) with depot leuprolide acetate (LA) in patients with recurrent pelvic pain following laparoscopic surgery for endometriosis.

Design

Prospective randomized trial.

Setting

Zagazig University hospitals, Egypt.

Patients

Two hundred and forty-two patients with recurrent pelvic pain following laparoscopic surgery for endometriosis.

Intervention

Dienogest (2 mg/day, orally) or depot LA (3.75 mg/4 weeks, intramuscularly) for 12 weeks.

Main Outcome Measures

A visual analogue scale was used to test the intensity of pain before and after the end of treatment.

Results

There was highly significant reduction in pelvic pain, back pain and dyspareunia in both groups with mean of difference in dienogest group (28.7 ± 5.3, 19.0 ± 4.3 and 20.0 ± 3.08 mm, respectively) and in LA group (26.2 ± 3.01, 19.5 ± 3.01 and 17.9 ± 2.9 mm, respectively). The most frequent drug-related adverse effects in dienogest group were vaginal bleeding and weight gain (64.5 and 10.8%, respectively) which were significantly higher than LA group (21.5 and 3.3%, respectively). While the most frequent drug-related adverse effects in LA group were hot flushes and vaginal dryness (46.3 and 15.7%, respectively) which were significantly higher than dienogest group (15.7 and 3.3%, respectively).

Conclusion

Daily dienogest is as effective as depot LA for relieving endometriosis-associated pelvic pain, low back pain and dyspareunia. In addition, dienogest has acceptable safety, tolerability and lower incidence of hot flushes. Thus, it may offer an effective and well-tolerated treatment in endometriosis.

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Acknowledgements

The authors would like to thank all the staff members of the Department of Obstetrics and Gynecology, Faculty of medicine, Zagazig University hospitals as well as all included women for their valuable contribution in this work.

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Authors and Affiliations

  1. Department of Obstetrics and Gynecology, Faculty of Medicine, Zagazig University, Mohamed Eltokhy Street, Zagazig City, Sharkia, Egypt

    Ahmed Mahmoud Abdou, Islam Mohamed Magdi Ammar, Amr Abd Almohsen Alnemr & Amr Ahmed Abdelrhman

Authors
  1. Ahmed Mahmoud Abdou
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  2. Islam Mohamed Magdi Ammar
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  3. Amr Abd Almohsen Alnemr
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  4. Amr Ahmed Abdelrhman
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Contributions

AMA: project development, IMMA: data analysis and manuscript revision, AAAA: data collection, AAA: manuscript writing

Corresponding author

Correspondence to Islam Mohamed Magdi Ammar.

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Conflict of interest

All authors declare that there is no conflict of interest with other people or organizations that could inappropriately influence or bias the content of the paper.

Ethical approval

All procedures performed in this study involving human participants (administration of oral dienogest 2 mg once daily or intramuscular leuprolide acetate depot 3.75 mg injection every 4 weeks for 12 weeks for patients with recurrent pelvic pain following laparoscopy for endometriosis) were in accordance with the ethical standards of the Faculty of Human Medicine—Zagazig University and with the 1964 Declaration of Helsinki and its later amendments and were approved by the IRB (Institutional Review Board). The study protocol, the intervention involved, possible early and long-term side effects of interventions were explained to the patients. After approval of the local ethics committee, a written informed consent was obtained from all patients before participating in the study.

Informed Consent

Written informed consent was obtained from all patients before participating in the study.

Additional information

Ahmed Mahmoud Abdou, M.D., is a Lecturer and Consultant of Obstetrics and Gynecology, Faculty of Medicine, Zagazig University, Egypt.

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Abdou, A.M., Ammar, I.M.M., Alnemr, A.A.A. et al. Dienogest Versus Leuprolide Acetate for Recurrent Pelvic Pain Following Laparoscopic Treatment of Endometriosis. J Obstet Gynecol India 68, 306–313 (2018). https://doi.org/10.1007/s13224-018-1119-3

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  • DOI: https://doi.org/10.1007/s13224-018-1119-3

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