A new, effective, non-surgical treatment for uterine fibroids can help women with this condition maintain their fertility, an American scientist told the 26th annual meeting of the European Society of Human Reproduction and Embryology in Rome.
Dr. Alicia Armstrong, Chief, Gynecologic Services, National Institutes of Health (NIH) said that the outcome of two Phase II clinical trials of ulipristal acetate (UPA) had significant implications for both infertility and general gynecology patients.
UPA belongs to a relatively new class of drug, the selective progesterone receptor modulators or SPRMs. It is currently used for emergency contraception, and acts by blocking the progesterone receptor and hence ovulation (release of the egg). Recent research has shown that progesterone also plays a role in the development of uterine fibroids, which affect 24 million women in Europe and can lead to a range of symptoms such as abdominal pain and discomfort and heavy and irregular menstrual bleeding.
Fibroids are the major indication for hysterectomy in Europe and the US, and they also contribute to infertility by interfering with the ability of the embryo to implant in the womb and causing miscarriage.
“Both the fibroids and the surgical interventions commonly used to treat them can cause significant fertility problems,” said Dr. Armstrong, “and we wanted to see whether fibroids could shrink and surgery could be avoided by using an SPRM.”
Results from two Phase II randomized, placebo-controlled, double-blinded studies performed at NIH were pooled and analyzed. In the trials, women aged from 25-50 years with symptomatic uterine fibroids were randomized to receive UPA or placebo once a day for three menstrual cycles. The researchers found that those taking UPA had reduced total fibroid volume, with those taking the higher dose doing better.
UPA also reduced bleeding compared with placebo. 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.
“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.”