Neoplasms

All Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Leiomyoma

Hemorrhage

Myofibroma

Uterine Hemorrhage

Menorrhagia

Metrorrhagia

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Menstruation Disturbances

Asoprisnil

Medical Director

The objective of this study is to determine the long-term safety of asoprisnil in women with symptomatic uterine fibroids who completed the 6 month Study C02-037.

No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids in women and many women must resort to surgery for relief. The objective of this study is to determine the long-term safety of asoprisnil 10 and 25 mg administered daily for 18 months to subjects with symptomatic uterine leiomyomata who completed the 6 month Study C02-037. The safety endpoints for this study will be based on assessments of the endometrium, ovarian cysts, lipid profiles, adverse events and clinical laboratory evaluations.

Some subjects receiving asoprisnil developed endometrial changes. As a result, dosing was prematurely discontinued for all subjects. To ensure safety, subjects will remain on study and will undergo scheduled study procedures. In most subjects, endometrial changes reversed after asoprisnil discontinuation.

Safety of Treatment of Uterine Fibroids With Asoprisnil

A Phase III, 18-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects With Uterine Leiomyomata

Abbott

Cynthia Mattia-Goldberg

Nervous System Diseases

Pain

Pelvic Pain

Neurologic Manifestations

All Drugs and Chemicals

Reproductive Control Agents

Relugolix

Estradiol 17 beta-cypionate

Estradiol 3-benzoate

Estradiol

Polyestradiol phosphate

Norethindrone

Norethindrone Acetate

Participants will be asked to take a once-daily tablet of Myfembree ( relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) for 24 months.

The standard of care will depend on the participant's type of surgery, health history, and clinical symptoms. It often includes pain management, bleeding management, physical exams, pelvic ultrasound, birth control, and Surgical reintervention.

patients who do not consent to randomization or opt to be in a specific group will be included in a parallel observational study and be administered their preferred treatment.

The study drug Myfembree will be taken orally with water, once daily, at approximately the same time, with or without food. Each tablet of Myfembree contains Relugolix 40mg, estradiol 1mg, and norethindrone acetate 0.5 mg.

Myfembree Oral Product

Obianuju Sandra Madueke Laveaux, MD MPH

Samar Alkhrait, MD

Obianuju Sandra Madueke Laveaux, MD,MPH

Obianuju Sandra madueke Laveaux, MD,MPH

In this project, the proposition is that the use of daily dosed Myfembree ( a combination of relugolix with estradiol and norethindrone acetate), FDA-approved medication to treat heavy menses fibroid-related symptoms, has the potential to delay the recurrence of fibroid symptoms, prolong the improved quality of life and delay the need for re-intervention after uterine sparing surgery versus the routine standard of care.

Surgical Myomectomy Followed by Oral Myfembree Versus Standard of Care Trial (SOUL)

Surgical Myomectomy Followed by Oral Myfembree Versus Standard of Care Trial.

Fibroid recurrence when compared to the post-myomectomy baseline pelvic ultrasound (transvaginal and/or transabdominal), defined as a new fibroid identified on ultrasound with a volume \>1 cm3.

The Quality of life questionnaire: UFS-QOL ( Uterine Fibroid symptoms \& Health Related-Quality of Life) is a self-reported questionnaire used to measure symptoms and health-related quality of life in women with uterine fibroids. The questionnaire contains 8 items concerning uterine fibroid symptoms and 29 items concerning health-related quality of life. Each item has a score (1-5), and the scores are summed so that a higher score indicates a higher quality of life.

The Work Productivity and Activity Impairment Questionnaire( WPAI: SHP) is a self-reported questionnaire assessing the effects of a participant's problem on her ability to work and perform activities on a scale from 0 (problem had no effect on daily activities) to 10 ( problem completely prevent doing daily activities).

The Female Sexual Function Index (FSFI) is a self-reported questionnaire that assesses different domains of sexual function in addition to providing an overall score regarding sexual function. The possible total score ranges from 2 to 36.

The Pictorial Bleeding Assessment Chart is a visual scoring system where the participant can directly record the number of her used feminine items (tampons and pads) and the degree to which they are bloodstained.

The Numerical Rating Scale is a subjective measure in which participants rate their pain on an eleven-point. Possible scores range from 0(no pain) to 10 (worst possible pain).

This will be measured based on the participant's reported symptoms and response to treatment. The re-intervention may include repeat myomectomy, uterine fibroid embolization, radiofrequency ablation, or hysterectomy.

Myovant Sciences GmbH

University of Chicago

Asoprisnil 10 mg Tablet, oral Daily for 6 months

Asoprisnil 25mg Tablet, oral Daily for 6 months

Placebo

The objective of this study is to determine the safety and efficacy effects of two doses of asoprisnil (10 mg and 25 mg) compared with placebo when administered daily for 6 months to premenopausal subjects with symptomatic uterine leiomyomata.

No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids. Asoprisnil (10 mg and 25mg) is being evaluated in a Phase 3 program to establish long term safety and effectiveness and therefore provide women with a medical alternative to surgery.

A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids

A Phase 3,6-Month, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Two Doses of Asoprisnil Versus Placebo in Subjects With Uterine Leiomyomata

Rare Diseases

Uterine Cervical Dysplasia

Precancerous Conditions

Uterine Cervical Diseases

Cervical Intraepithelial Neoplasia

Minimally invasive hysterectomy by robotic surgery

Minimal invasive hysterectomy by vaginal or traditional laparoscopic surgery.

Minimally invasive hysterectomy for benign disorders. Comparing robotic hysterectomy with vaginal hysterectomy and traditional laparoscopic hysterectomy

Robotic hysterectomy

Benign hysterectomy performed by traditional minimal invasive procedures.

Vaginal or laparoscopic hysterectomy

Jan Persson, MD, PhD

A randomised controlled trial comparing hysterectomy by minimally invasive surgical methods; robotic hysterectomy versus vaginal hysterectomy or traditional laparoscopic hysterectomy; outcome and cost analyses.

Laparoscopic surgery is advantageous compared to open surgery in terms of patient morbidity, shorter hospitalization and a more rapid return to daily activities. Robot-assisted laparoscopic surgery have facilitated a higher proportion of minimally invasive surgery first and foremost within gynecologic oncology.It is not clear whether or not this is true for less advanced surgery where a vaginal approach or a traditional laparoscopic approach is possible.

Robot-assisted surgery is associated with additional cost due to investment and more expensive surgical equipment. The study is performed to investigate whether or not performing hysterectomy for benign conditions with robotic surgery will be advantageous in terms of shorter operating time, less complications, less conversions to open surgery, and shorter hospital stay in comparison to other minimally invasive procedures such as vaginal hysterectomy and traditional laparoscopic hysterectomy.

Minimally Invasive Benign Hysterectomy

Benign Hysterectomy; a Randomized Controlled Trial Comparing Robotic Hysterectomy With Vaginal Hysterectomy and Traditional Laparoscopic Hysterectomy

The length of postoperative sick leave and reasons for extending sick leave and cost thereof.

The cost of surgery includes the actual surgery (anaesthesia, OR-nurse, circulating nurse, doctors and use of the OR) as well as the length of the inpatient stay. The cost for conversions to open surgery, reoperations, readmissions, and any additional cost associated with additional procedures or medical interventions such as radiological examinations and blood transfusions. Based on the estimated cost of surgical material, use of the operating room and cost of anaesthesia each benign hysterectomy performed with robotic surgery would need to be 50 minutes shorter than other minimal invasive procedures to compensate for the additional cost.

The number of patients in whom an intraoperative or postoperative complication occurs as well as the seriousness of the complication which occurs and what this entails for the patient in question. This includes conversions to open surgery as well as the need for reoperation and readmission.

Region Skane

The objective of this study is to determine the long-term safety of asoprisnil in women with abnormal uterine bleeding associated with uterine fibroids.

No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids in women and many women must resort to surgery for relief. The objective of this study is to determine the long-term safety of asoprisnil 10 and 25 mg tablets administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids after an initial 12 months in M01-390 or M01-394. The safety endpoints for this study will be based on assessments of the endometrium, ovarian cysts (if applicable), bone and lipid profiles, adverse events, and changes from baseline laboratory values and vital signs.

Some subjects receiving asoprisnil developed endometrial changes. As a result, dosing was prematurely discontinued for all subjects. To ensure safety, subjects will remain on study and will undergo scheduled study procedures. In most subjects, endometrial changes reversed after asoprisnil discontinuation.

Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids

A Phase 3, 12-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects With Uterine Leiomyomata

Infections

Endometriosis

Adenomyosis

Pelvic Inflammatory Disease

Pelvic Infection

Communicable Diseases

Adnexal Diseases

Total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy

Laparoscopic hysterectomy

Abdominal hysterectomy

Kimberly Kho, MD, MPH

The purpose of the proposed pilot study is to investigate the effectiveness, cost, safety, and long-term impact on quality of life of laparoscopic hysterectomy (LH) in relation to abdominal hysterectomy (AH) for the treatment of benign gynecologic disease in women through a randomized surgical trial.

The overall hypothesis is that neither mode of hysterectomy will be consistently superior to the other with respect to each of the three domains of complications, cost, and patient-centered outcomes. The overall goal of the study is to determine which clinically relevant factors may impact the choice of LH compared to AH. The results of the study may be useful for clinicians, patients, hospital administrators and health policy makers.

Surgical Success After Laparoscopic vs Abdominal Hysterectomy

Randomized Trial of Laparoscopic Versus Abdominal Hysterectomy for Benign Indications and Impact on Surgical Success

1) Patient-centered outcomes composite

1. Quality of life - measured using the Short Form 12 (SF-12v2),
2. Sexual functioning - measured using the Sexual Activity Questionnaire (SAQ)
3. Body image - measured using the Body Image Scale (BIS)
4. Return to normal activity -measured using the Activities Assessment Scale (AAS)
5. Pain - measured using a 10 point likert scale
6. Productivity - measured using a questionnaire about missed work

Hospital charges and indirect costs of missed work/caregiving due to hysterectomy will be calculated

Intraoperative and postoperative complications including conversions, unintentional lacerations/injury to organs, hemorrhage, infection, wound complications, VTE, death, pain, neuropathy

University of Texas Southwestern Medical Center

Associate Professor, Department of Obstetrics and Gynecology

Asoprisnil 10 mg Tablet, oral Daily for up to 2 years

Asoprisnil 25 mg Tablet, oral Daily for up to 2 years

No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids in women and many women must resort to surgery for relief. The objective of this study is to determine the long-term safety of two asoprisnil doses (10 and 25 mg tablets) administered daily to women who received asoprisnil in one of the asoprisnil long-term studies (study C03-062 or study M01-391). The safety endpoints for this study will include the affects of asoprisnil on the endometrium, ovaries, bone (a subset of study M01-391 subjects), lipid profiles, adverse events, and changes from baseline lab values and vital signs.

Some subjects receiving asoprisnil developed endometrial changes. As a result, dosing was prematurely discontinued for all subjects. To ensure safety, subjects will remain on study and will undergo scheduled study procedures. In most subjects, endometrial changes reversed after asoprisnil discontinuation.

Study of Asoprisnil in the Treatment of Uterine Fibroids.

A Phase 3, Continuation Study to Evaluate the Long-Term Safety of Asoprisnil in Subjects With Uterine Leiomyomata

The objective of this study is to determine the safety and effectiveness of asoprisnil in symptomatic women with abnormal uterine bleeding associated with uterine fibroids.

No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids in women and many women must resort to surgery for relief. The objective of this study is to determine the safety and efficacy of asoprisnil 10 mg and 25 mg tablets, compared to placebo, administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids, by assessing whether asoprisnil administration prevents surgical and/or invasive intervention in the study population. Women, who meet the predefined uterine bleeding criteria for surgical and/or invasive intervention (hysterectomy, myomectomy, uterine artery embolization) who are willing to undergo surgical and/or invasive intervention if the study medication fails, will be enrolled in this study.

A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids

A Phase III, 12-Month, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Two Doses of J867 Versus Placebo in Subjects With Uterine Leiomyomata.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety of Treatment of Uterine Fibroids With Asoprisnil	NCT00156208	Fibroid Uterus Leiomyoma Menorrhagia Metrorrhagia Uterine Fibroid...	Asoprisnil Asoprisnil	18 Years -	Abbott
Surgical Myomectomy Followed by Oral Myfembree Versus Standard of Care Trial (SOUL)	NCT05538689	Metrorrhagia Pelvic Pain Menorrhagia Leiomyoma	Myfembree Oral ...	18 Years -	University of Chicago
Safety of Treatment of Uterine Fibroids With Asoprisnil	NCT00156208	Fibroid Uterus Leiomyoma Menorrhagia Metrorrhagia Uterine Fibroid...	Asoprisnil Asoprisnil	18 Years -	Abbott
A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids	NCT00152256	Fibroid Uterus Leiomyoma Menorrhagia Metrorrhagia Uterine Fibroid...	Asoprisnil Asoprisnil Placebo	18 Years - 53 Years	Abbott
Minimally Invasive Benign Hysterectomy	NCT01865929	Menorrhagia Metrorrhagia Uterine Fibroid... Cervical Dyspla...	Robotic hystere... Vaginal or lapa...	25 Years -	Region Skane
Minimally Invasive Benign Hysterectomy	NCT01865929	Menorrhagia Metrorrhagia Uterine Fibroid... Cervical Dyspla...	Robotic hystere... Vaginal or lapa...	25 Years -	Region Skane
Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids	NCT00156195	Leiomyoma Menorrhagia Metrorrhagia	Asoprisnil Asoprisnil	18 Years -	Abbott
Surgical Success After Laparoscopic vs Abdominal Hysterectomy	NCT01793584	Metrorrhagia Menorrhagia Leiomyoma Adenomyosis Pelvic Pain Endometriosis Pelvic Inflamma...	Laparoscopic hy... Abdominal hyste...	18 Years - 80 Years	University of Texas Southwestern Medical Center
Study of Asoprisnil in the Treatment of Uterine Fibroids.	NCT00156156	Fibroid Uterus Leiomyoma Menorrhagia Metrorrhagia Uterine Fibroid...	Asoprisnil Asoprisnil	18 Years -	Abbott
Minimally Invasive Benign Hysterectomy	NCT01865929	Menorrhagia Metrorrhagia Uterine Fibroid... Cervical Dyspla...	Robotic hystere... Vaginal or lapa...	25 Years -	Region Skane
Surgical Myomectomy Followed by Oral Myfembree Versus Standard of Care Trial (SOUL)	NCT05538689	Metrorrhagia Pelvic Pain Menorrhagia Leiomyoma	Myfembree Oral ...	18 Years -	University of Chicago
Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids	NCT00156195	Leiomyoma Menorrhagia Metrorrhagia	Asoprisnil Asoprisnil	18 Years -	Abbott
A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids	NCT00160381	Leiomyoma Menorrhagia Metrorrhagia	Asoprisnil Asoprisnil Placebo	18 Years -	Abbott

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We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.