The treatment of severe premenstrual syndrome with goserelin with and without 'add-back' estrogen therapy: a placebo-controlled study

Gynecol Endocrinol. 1999 Feb;13(1):48-55. doi: 10.1080/09513599909167531.

Abstract

The study aimed to determine if the addition of daily low-dose oral estrogen with a cyclical progestogen given to young women using a depot gonadotropin-releasing hormone (GnRH) analog implant for the treatment of their premenstrual syndrome (PMS) would affect the clinical outcome. In a double-blind placebo-controlled study in a specialist premenstrual syndrome clinic setting, 60 women aged between 20 and 45 years were randomized to one of three treatment groups: Group A (placebo implant four weekly + placebo tablets daily), Group B (goserelin 3.6 mg implant four weekly + estradiol valerate 2 mg daily with norethisterone 5 mg from days 21-28 of a 28-day cycle) or Group C (goserelin 3.6 mg implant four weekly + placebo tablets daily). Differences between PMS scores at 2, 4 and 6 months were compared with pretreatment values. There was a significant improvement in PMS scores in Group C (Zoladex + placebo) after 2, 4 and 6 months of treatment when compared to pretreatment values and Group A (placebo + placebo). The addition of a low-dose oral estrogen with a cyclical progestogen to GnRH analog treatment (Group B) resulted in a less dramatic response when compared to pretreatment values and no significant improvement when compared to Group A (placebo + placebo) at 2, 4 and 6 months of treatment. The addition of a low-dose oral estrogen with a cyclical progestogen to depot GnRH analog therapy in the treatment of PMS reduces the clinical response.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adult
  • Delayed-Action Preparations / therapeutic use
  • Double-Blind Method
  • Drug Therapy, Combination
  • Estradiol / therapeutic use*
  • Estrogen Replacement Therapy*
  • Female
  • Goserelin / therapeutic use*
  • Humans
  • Middle Aged
  • Norethindrone / therapeutic use
  • Premenstrual Syndrome / drug therapy*
  • Progesterone Congeners / therapeutic use*
  • Surveys and Questionnaires

Substances

  • Delayed-Action Preparations
  • Progesterone Congeners
  • Goserelin
  • Estradiol
  • Norethindrone