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2 Study Matches
M16-824 A phase 3 Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated with Uterine Fibroids in Premenopausal Women.
The purpose of this study is to determine the safety and effectiveness of elagolix 150 mg once daily and how this dosage of elagolix works when compared to placebo in reducing heavy menstrual bleeding, the major symptom of uterine fibroids. Elagolix is an investigational drug which suppresses the production of estrogen depending on the dose. Because Elagolix can reduce the estrogen below the normal level, it is being tested for the treatment of symptoms of endometriosis and uterine fibroids, two conditions are that hormone-dependent. Participation in this study will last approximately up to 22 months and include approximately 10-12 study visits to the research center and approximately 4 visits that will be conducted over the phone.
18 year(s) or older
Inclusion Criteria:Premenopausal women, 18
•51 years old
Diagnosis of uterine fibroids with heavy menstrual bleeding
Regular menstrual cycles between 24
•38 days in length
Must agree to use at least 2 forms of non-hormonal contraception throughout the study period.
Exclusion Criteria:No osteoporosis or other metabolic bone disease
No history of suicide ideation or attempts
Not currently pregnant, breastfeeding or planning to become pregnant until study completion
Role of microRNA activation of lectin-like oxidized LDL receptor (LOX-1) mechanisms in microvascular dysfunction in women with endometriosis
Endometriosis is a gynecological disorder associated with chronic pelvic pain, pain during intercourse, and infertility. With endometriosis, endometrium-like tissue is found in sites outside the uterine cavity. This disorder affects 6% - 10% of women of reproductive age. It can be as high as 35-50% in women who have pain or infertility. Endometriosis is associated with higher risk of hypercholesterolemia and hypertension that increases risk for cardiovascular disease (CVD). CVD is characterized by dysfunction of the blood vessels of the body. CVD is the leading cause of death in women. Two groups of women complete this study: 1) healthy women between the ages of 18 and 45 years (Controls); 2) women between the ages of 18 and 45 years with endometriosis. The screening and two experiments include blood draws. After passing a medical screening, each subject participates in a microdialysis (MD) experiment before and after 6-9 days of oral atorvastatin therapy (10mg/day). Atorvastatin (brand name: Lipitor) is an FDA-approved drug that physicians prescribe to lower blood cholesterol. The atorvastatin also suppresses substances made by the body that increase the risk of CVD. MD is a procedure in which a thin tube of membrane that mimics a capillary blood vessel is implanted in the skin. Substances of interest are added to the saline flowing through the MD sites and are delivered into small areas of skin. The MD experiments combine the perfusion of the test-substances with local heating of the skin to explore the causes for the dysfunction of blood vessels and increased risk for CVD that occurs with endometriosis.
18 year(s) or older
Inclusion Criteria:Women, Ages 18-45
Do or do not have endometriosis
Have normal blood pressure
Exclusion Criteria:Use of nicotine-containing products (e.g. smoking, chewing tobacco, etc.)
High Blood Pressure
Abnormal liver function
Known allergy statins (Lipitor)
Pregnant or Breastfeeding
Heart & Vascular, Pregnancy & Infertility, Women's Health