Are you a woman feeling distressed due to uterine fibroids? Does this burdensome disease affect your daily activities? If so, this clinical trial evaluates a drug to help alleviate some of your symptoms and improve your quality of life.
A clinical trial has investigated the effectiveness of a drug regimen called Relugolix combination therapy for reducing symptoms and improving quality of life in women with troublesome fibroids.
Uterine fibroids are non-cancerous growths that develop in the uterus, affecting millions of women worldwide. They can cause heavy periods, pelvic pain, and discomfort. The standard treatment options for fibroids include surgery and medication, which often come with side effects and risks.
A treatment regimen has gained popularity for managing women with symptomatic fibroids. This regimen, called Relugolix combination therapy, consists of three drugs given once daily:
- 40 mg relugolix
- 1 mg estradiol
- 0.5 mg norethindrone acetate
Relugolix is a medication that works by reducing the amount of estrogen and progesterone in the body, which are hormones that stimulate the growth of fibroids. However, strong clinical data on the effectiveness of this combination in reducing fibroid symptoms and improving health-related quality of life in these women is lacking.
A clinical trial has attempted to measure these variables in women with uterine fibroids.
The clinical study, called the LIBERTY randomized trials, consisted of two replicate clinical trials named LIBERTY 1 and LIBERTY 2. These trials evaluated the use of relugolix combination therapy for treating fibroids. These trials focused on the following aspects of daily life: concern, activities, energy or mood, control, self-consciousness, and sexual function. Additionally, they measured the severity of symptoms and the impact of uterine fibroids on physical and social activities.
The clinical study involved 509 women with fibroids who were randomly assigned to receive either relugolix combination therapy or a placebo. The participants were followed for up to 24 weeks, and their symptoms and quality of life were evaluated using standardized questionnaires.
The results of the clinical trial showed that women who received relugolix combination therapy had significant improvements in their quality of life compared to those who received a placebo. They also reported a reduction in symptoms of fibroids, such as heavy bleeding and pelvic pain, and had better overall physical and mental health.
The clinical study also found that the relugolix combination therapy was safe and well-tolerated, with few side effects reported.
In conclusion, the findings of the LIBERTY clinical trials suggest that relugolix combination therapy may be a promising new treatment option for women with uterine fibroids. It may offer a safe and effective alternative to surgery and other medications, improving the quality of life for millions of women worldwide. Women considering relugolix combination therapy should discuss the potential risks and benefits with their healthcare provider.
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American Journal of Obstetrics and Gynecology, Nov-09-22
ClinicalTrials.gov: NCT03049735, NCT03103087
ClinicalTrials.gov: NCT03049735, NCT03103087