CHICAGO -- A novel formulation of intravaginal danazol significantly reduced chronic pelvic pain in a small study of women with endometriosis, Dr. Thomas Janicki said in a poster presentation at a meeting sponsored by the International Pelvic Pain Society.
Most importantly, there was a lack of systemic androgenic side effects, and low to undetectable plasma levels of danazol, indicating that the drug was acting locally, said Dr. Janicki, director of the Pelvic Pain Center at University Hospitals of Cleveland.
Treatment with oral danazol in women has been associated with excessive hair growth, weight gain, acne, and deepening of the voice.
The investigational preparation by FemmePharma Inc. of danazol gel that adheres to the vaginal wall was used in the study of 25 women with a prior surgical diagnosis of endometriosis and moderate to severe pain. Dr. Janicki received financial support for his study from FemmePharma and is a scientific advisor and stockholder in the company.
Of the women studied, 16 received 100 mg/day danazol for four menstrual cycles and 9 received 100 mg/day for three cycles and then switched to 200 mg/day for two additional cycles. The patients self-administered the danazol intravaginally with an applicator.
Pelvic pain was evaluated before, during, and after treatment using the Biberoglu and Behrman symptoms scale (BBSS), pain assessment questionnaires, and quality of life questionnaires.
There was a mean improvement of more than 50% in BBSS from baseline to the last visit at either 5 or 6 months (average 8.4 vs. 4.5, respectively). "The symptoms of dysmenorrhea, dyspareunia, pelvic pain, and pelvic tenderness all showed significant changes at the final visit compared with the first visit," Dr. Janicki said.
Pain assessment scores showed that average endometriosis pain experienced in the previous 4 weeks decreased by a mean 3.4 points from screening to end of treatment, and that worst endometriosis pain experienced in the previous 4 weeks decreased by 3.0 points.
On the quality of life questionnaire, 79% of women reported improvement from baseline.
One case each of mild facial acne, mild nausea, bloating, and mild abdominal pain, and three cases of vaginal irritation were reported. All of the women in the small, open-label, single-arm, multicenter study retained their menses and ovulation.
BY PATRICE G. W. NORTON
COPYRIGHT 2004 International Medical News Group
COPYRIGHT 2004 Gale Group