Copper IUD Treatment Observation Study
MenorrhagiaStudies indicate that bleeding irregularities and dysmenorrhea are common reasons for copper IUD method discontinuation. Some evidence suggests that non-steroidal anti-inflammatory medications (NSAIDs) can help improve bleeding during Cu-IUD use. However, these studies did not examine NSAID use with the TCu380A specifically, nor did they evaluate readily available NSAIDs such as over-the-counter naproxen. For this reason, the investigators propose a pilot trial in which new TCu380A users complaining of heavy or prolonged menstrual bleeding or spotting after 1 month of use are randomized to naproxen or placebo to be taken the first 7 days of menstruation for three consecutive cycles, and then observed for one cycle without treatment.
Mirena Extension Trial
ContraceptionThe study is performed to assess if Mirena is effective and safe as a birth control method beyond 5 years of use. Further the menstrual blood loss (in women that had Mirena inserted for the indication heavy menstrual bleeding [HMB]) and safety will be assessed.
Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding...
Uterine LeiomyomaUterine FibroidsThe objectives of this randomized withdrawal study are to evaluate the long-term efficacy and safety of the combination of relugolix, estradiol (E2) and norethindrone acetate (NETA), once daily, for up to 104 weeks in patients with uterine fibroids who have completed a total of 52 weeks of treatment, including a 24-week treatment period in a parent study (study MVT-601-3001 or MVT-601-3002) and a 28-week treatment period in the open-label extension study (MVT-601-3003), and who meet the definition of responder, defined as a patient who demonstrates a menstrual blood loss of < 80 mL and at least a 50% reduction from parent study baseline menstrual blood loss volume on the alkaline hematin analysis of the feminine products returned at Week 48 in the extension study.
Registry Study of Genesys HTA for Treatment of Menorrhagia
MenorrhagiaThis is a clinical registry of an FDA approved device system called the Genesys Hydro ThermAblatorTM (HTA) system (Boston Scientific). The HTA system's intended use is to be inserted, by a trained physician, into the uterus, where it will fill and circulate fluid that is warm enough to change the characteristics of the uterine lining. This is done with the anticipated result of improving menstrual bleeding symptoms. The purpose of this FDA-mandated registry is to obtain clinical experience on the use the Genesys HTA™ system, under normal clinical conditions, and document its safety and technical reliability.
A Study of Tranexamic Acid (XP12B) in Women With Heavy Menstrual Bleeding
MenorrhagiaThis was a multicenter, open-label extension study for subjects completing either of 2 pivotal efficacy studies (NCT00401193 or NCT00386308). The study consisted of a treatment phase of 9 menstrual periods to assess the safety of tranexamic acid at an oral dose of 1.3 g administered 3 times per day for up to 5 days (maximum of 15 doses) during menstruation. After the last treatment period, a follow-up phone call occurred approximately 30 days (range 25 to 35 days) after the last dose of study drug.
Uterine Balloon Treatment for Heavy Period Bleeding.
MenorrhagiaThe purpose of this research is to determine the proportion of women who achieve permanent cessation of bleeding after Uterine Balloon Therapy (UBT) for the treatment of heavy uterine bleeding.
Efficacy and Safety Study of XP12B in Women With Menorrhagia
MenorrhagiaHeavy Menstrual BleedingThe purpose of this study is to determine whether XP12B is effective and safe in the treatment of women with heavy menstrual bleeding associated with menorrhagia.
Bleeding Pattern and User Satisfaction During Second Consecutive MIRENA® in Contraception and Treatment...
ContraceptionMenorrhagiaThe purpose of this study is to assess the bleeding pattern during the last 3 months of the first MIRENA® and the first year of the second MIRENA® use.
Emmy Trial: Uterine Artery Embolization (UAE) Versus Hysterectomy for Uterine Fibroids
MenorrhagiaLeiomyoma1 moreThe Emmy trial is set up to evaluate the safety and efficacy of uterine artery embolization (UAE) in comparison to hysterectomy for the treatment of symptomatic uterine fibroids. UAE was considered equivalent to hysterectomy when at least 75% of patients had normalization of heavy menstrual blood loss after treatment.
A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids...
LeiomyomaMenorrhagia1 moreThe objective of this study is to determine the safety and effectiveness of asoprisnil in symptomatic women with abnormal uterine bleeding associated with uterine fibroids.