Clinical Trials

Meditrina is currently conducting phase II clinical research with MPI-674 towards improving outcomes for women undergoing ablation to treat menorrhagia, more commonly known as abnormal uterine bleeding (AUB).  The technical definition of menorrhagia is the occurrence of menstrual cycles that last longer than seven days and/or with blood loss that exceeds 80mL. This abnormal uterine bleeding or “heavy periods” are characterized by the need to change sanitary protection every hour and severely restrict a women’s ability to securely perform everyday tasks of daily living including work, social events, travel, and sleep without fear of a bleeding accident.  Left untreated, women can actually lose enough blood during their “heavy periods” to develop anemia, a serious medical condition.  For women who have finished their childbearing, hysterectomy was often employed to address heavy bleeding.  Today, less invasive surgical procedures known as endometrial ablation can be employed to address this issue while allowing a woman to retain her uterus and ovaries.

Endometrial ablation is a minimally invasive procedure where doctor removes the lining of the uterus (the uterus itself is not removed).  Methods include the use of heat, extreme cold, energy, or laser.  Following the procedure, periods will be a lot lighter or may stop altogether.

Some of these procedures can be performed at any time during the menstrual cycle. Many of the approved medical devices for these  procedures require a pre-treatment drug to prepare and thin the uterine lining to provide the best patient outcomes.  Currently, the pre-treatment drug must be injected a few weeks before the procedure.  Meditrina is evaluating MPI-674 as an oral drug that can be administered a for a short time prior to the endometrial ablation.  A US-based, multi-center, placebo-controlled phase II clinical trial is currently enrolling premenopausal women with the primary objective of evaluating the appropriate time during the menstrual cycle to initiate dosing to either induce or maintain a thin endometrium (protocol M001).  With crucial dose timing data from this trial, Meditrina will progress to a subsequent phase II dose ranging trial (protocol M002) followed by a pivotal phase III trial (M003) scheduled to begin in early 2008.

In the future, Meditrina plans to seek additional indications for its proprietary drug candidates that will further improve treatment options for patients suffering from women’s health disorders with serious unmet needs such as ectopic pregnancy, endometriosis and uterine fibroids.