Lhomme, C., Brault, P.H., Bourhis, J.H., Pautier, P., Dohollou, N., Dietrich, P.Y., . . . Hayat, M. (2001). Prevention of menstruation with leuprorelin (GnRH agonist) in women undergoing myelosuppressive chemotherapy or radiochemotherapy for hematological malignancies: A pilot study. Leukemia and Lymphoma, 42, 1033–1041.

DOI Link

Intervention Characteristics/Basic Study Process

  • Median injections per patient: 4 (1–14) greater than 100K
  • If TBI, leuprorelin stopped two months after irradiation
  • Leuprorelin 3.75 mg subcutaneous every 28 days (except second administration at 21 days) until finishing chemotherapy and stable platelet count
  • Nomegestrol acetate 10 mg days 1–35 and then as needed and combined with leuprorelin in the case of moderate or heavy bleeding  
  • Six of 20 received oral contraceptives.
  • Four received progestin only; two out of four of these were amenorrheic.

Sample Characteristics

  • N = 21 patients enrolled (one not eligible)
  • AGE = 16–50 years
  • MEDIAN AGE = 33 years
  • WOMEN: 100%
  • KEY DISEASE CHARACTERISTICS: Leukemia, Hodgkin disease, nonHodgkin lymphoma, or multiple myeloma with or without transplant
  • OTHER KEY SAMPLE CHARACTERISTICS: Women undergoing myelosuppressive therapy with platelet nadir expected to be less than 100K. Platelet nadir was less than 20K in 17 patients.



 

Measurement Instruments/Methods

  • Efficacy was assessed clinically.
  • Failure was defined by the occurrence of bleeding.
  • Hormonal efficacy was checked by plasma assay of estradiol, follicle-stimulating hormone, and luteinizing hormone.
     

Results

Nineteen bleeding episodes occurred in 11 patients. Three patients required additional treatment, including additional nomegestrol acetate, methylergometrine, and/or platelet transfusions. Eleven episodes of spotting and six episodes of moderate bleeding not requiring treatment occurred in 10 patients. The majority of bleeding episodes were short with a median of three days (1–23). Seventeen patients had no clinically or therapeutically relevant bleeding. There was no premature termination because of toxicity. There was one subcutaneous nodule at injection site and eight superficial hematomas.

 

Limitations

  • Seven of 21 patients were terminated early because of TBI (patients without vaginal bleeding) or patient death because of disease progression (3 of 20 patients); one patient of 20 was lost to follow-up.
  • Small sample size completed treatment.
  • No mention of controlling for comorbidities/other risk factors or actual nadir