UPA also reduced bleeding compared with placebo and during the third month of treatment 16 (80%) of patients taking 10mg daily and 18 (95%) on a daily dose of 20mg experienced no menstrual bleeding. At the end of the treatment, patients on the active treatment scored higher in assessment of their quality of life, the severity of their symptoms, their energy levels and mood and their overall concern about the effects of fibroids.
Estradiol levels remained adequate for bone health during treatment in 77%, 100% and 95% of patients in the UPA 10mg and 20mg and placebo groups, respectively, indicating that the action of the ovaries was not impaired, and neither were there any serious side effects. Some women taking UPA had transient increases in liver function tests and a few had the changes in the endometrium that have previously been seen with this class of compounds.
"The results of these trials are convincing and lead us to conclude that UPA is an effective non-invasive treatment for fibroids that can help maintain fertility in women whose only option up to now was to have surgery," said Dr. Lynnette Nieman, Principal Investigator on the NIH trials. "We hope that the results from these trials, along with those from the Phase III trials currently being conducted by the Swiss company PregLem SA, will allow us to offer this treatment to women who do not want surgery or are unable to have it for medical reasons."
Researchers at the National Institute of Child Health and Human Development are currently carrying out further studies of the molecular action of UPA, Dr Nieman said. "These studies will not only help us understand how the
|Contact: Mary Rice|
European Society of Human Reproduction and Embryology