Publications by authors named "R S Wagman"
Article Synopsis
- Two clinical trials, LIBERTY 1 and LIBERTY 2, studied the effectiveness of relugolix combination therapy versus placebo in reducing heavy menstrual bleeding and pain in women with uterine fibroids over a 24-week period.
- Results showed that a significantly higher percentage of women on relugolix reported minimal or no menstrual (65% vs. 19%) and non-menstrual (45% vs. 22%) pain compared to those on placebo.
- The researchers concluded that relugolix combination therapy was effective in reducing pain from uterine fibroids, with many women experiencing a one-third reduction in their worst pain symptoms.
Article Synopsis
- Two clinical trials focused on the effectiveness of relugolix combination therapy for women experiencing heavy menstrual bleeding due to uterine fibroids.
- Participants self-reported their symptoms and quality of life before, during, and after a 24-week treatment with either relugolix or a placebo.
- Results indicated that women using relugolix reported reduced distress from fibroid symptoms and an overall improvement in their health-related quality of life compared to those on the placebo.
Study Question: What is the efficacy and safety of long-term treatment (up to 2 years) with relugolix combination therapy (CT) in women with moderate to severe endometriosis-associated pain?
Summary Answer: For up to 2 years, treatment with relugolix CT improved menstrual and non-menstrual pain, dyspareunia, and function in women with endometriosis; after an initial decline of <1%, the mean bone mineral density (BMD) remained stable with continued treatment.
What Is Known Already: Endometriosis is a chronic condition characterized by symptoms of dysmenorrhea, non-menstrual pelvic pain (NMPP), and dyspareunia, which have a substantial impact on the lives of affected women, their partners, and families. SPIRIT 1 and 2 were phase 3, randomized, double-blind, placebo-controlled studies of once-daily relugolix CT (relugolix 40 mg, oestradiol 1 mg, norethisterone acetate 0.
What Is This Summary About?: This is a summary of research studies (known as clinical trials) called SPIRIT 1 and SPIRIT 2. The SPIRIT 1 and SPIRIT 2 studies compared how well a medicine called relugolix combination therapy worked in relieving pain in women with moderate to severe endometriosis compared to a placebo, a pill with no active medication. Endometriosis occurs when tissue similar to what normally lines the uterus grows in other places, such as the ovaries, fallopian tubes, and bowels.
View Article and Find Full Text PDFBackground: In the pivotal LIBERTY 1 and 2 trials and long-term extension study, once-daily relugolix combination therapy (40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate) reduced menstrual blood loss volume and pain among women with uterine fibroids. Relugolix combination therapy was well tolerated with preservation of bone mineral density through 52 weeks.
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