Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Leiomyoma

Myofibroma

Fibroma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

Following the baseline assessment no treatment period, matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.

Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.

Following the baseline assessment no treatment period, telapristone acetate 12mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.

Matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.

Placebo

Telapristone acetate, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.

Telapristone Acetate

Anna Chan

The primary objective of this study is to determine the safety and efficacy of two vaginal doses of Proellex® administered for up to 2 courses of treatment (18 weeks each), each separated by an Off-Drug Interval (ODI), to premenopausal women with symptomatic uterine fibroids.

Safety and Efficacy of Telapristone Acetate (Proellex®) Administered Vaginally for the Treatment of Uterine Fibroids

A Phase 2, Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids

Amenorrhea was defined as any 28-day period during treatment (not including the ODI) without a bleeding intensity score \>1. Participants were provided with a daily diary and Pictorial Blood Loss Assessment Chart (PBAC) to record information about the menstrual blood loss (MBL). Bleeding intensity was graded on a 5-point scale where: 1=spotting to 5=heavy bleeding.

Amenorrhea was defined as any 28-day period during treatment (not including the ODI) without a bleeding intensity score \>1 after 2 courses of treatment. Participants were provided with a daily diary and (PBAC) to record information about the MBL. Bleeding intensity was graded on a 5-point scale where: 1=spotting to 5=heavy bleeding.

Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss. Participants recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Pictorial scores range from score 1 for slightly stained tampon/towel, 5 for a partially stained tampon/towel, 10 for a completely saturated tampon, 20 for a completely saturated towel, and 5 for each episode of flooding and for each blood clot larger than a quarter in size. Total score can range from 0 (no bleeding) to \>500. Higher scores indicate more bleeding. Lower scores indicate less bleeding. A negative change from Baseline indicates improvement (reduction in bleeding).

UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. Each question was answered on a 5-point scale where 1=Not at all to 5=A very great deal. The sum of the total scores was transformed to a range of 0=no symptoms (best) to 100=most severe symptoms (worst). A negative percentage change from Baseline indicates improvement.

UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 1: During the previous 3 months how distressed were you by "heavy bleeding during your menstrual period"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.

UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 2: During the previous 3 months how distressed were you by "passing blood clots during your menstrual period"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.

UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 3: During the previous 3 months how distressed were you by "fluctuation in the duration of your menstrual period compared to your previous cycle"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.

UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 4: During the previous 3 months how distressed were you by "fluctuation in the length of your monthly cycle compared to your previous cycles"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.

UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 5: During the previous 3 months how distressed were you by "feeling tightness or pressure in your pelvic area"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.

UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 6: During the previous 3 months how distressed were you by "frequent urination during the daytime hours"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.

UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 7: During the previous 3 months how distressed were you by "frequent nighttime urination"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.

UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 8: During the previous 3 months how distressed were you by "feeling fatigued"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.

The total uterine fibroid volume was measured by Magnetic Resonance Imaging (MRI). A negative change from Baseline indicates improvement.

Repros Therapeutics Inc.

Safety Population included all study participants who received at least 1 dose of study treatment.

Telapristone Acetate 6 mg

Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.

Telapristone Acetate 12 mg

Total

Age, Continuous

Sex: Female, Male

Black or African American

Native Hawaiian or Other Pacific Islander

White

Race/Ethnicity, Customized

Hispanic or Latino

Not Hispanic or Latino

Therapeutic Area, Head

Intent-to-Treat (ITT) population included all participants who were randomized and received study drug.

Percentage of Participants in Amenorrhea at the End of Treatment Course 1

ITT population included all participants who were randomized and received study drug.

Percentage of Participants in Amenorrhea at the End of Treatment Course 2

Percentage change in the last value on drug Course 1.

Percentage change in the last value on drug Course 2.

Percentage Change from BL: Course 1

Percentage Change from BL: Course 2

ITT population included all participants who were randomized and received study drug. Number analyzed is the number of participants with data available at the given time-point.

Percentage Change in PBAC Scores From Baseline to the End of Treatment Courses 1 and 2

Percentage Change: Course 2, Week 24 Follow-up

Percentage Change in Transformed Total Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit

Percentage Change from BL: Course 2, Week 24 Follow-up Visit

ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available at the given time-point.

Percentage Change in the Individual UFS-SSS Subscale Score Question 1 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit

Percentage Change in the Individual UFS-SSS Subscale Score Question 2 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit

Percentage Change in the Individual UFS-SSS Subscale Score Question 3 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit

Percentage Change in the Individual UFS-SSS Subscale Score Question 4 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit

Percentage Change in the Individual UFS-SSS Subscale Score Question 5 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit

Percentage Change in the Individual UFS-SSS Subscale Score Question 6 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit

Percentage Change in the Individual UFS-SSS Subscale Score Question 7 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit

Percentage Change in the Individual UFS-SSS Subscale Score Question 8 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit

Percentage Change in Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2

Treatment Course 1

Treatment Course 2

Myoma

Neoplasms, Fibrous Tissue

All Drugs and Chemicals

Vaccines

Immunomodulating Agents

A single oral pill of V3-Myoma therapeutic vaccine containing pooled antigens circulating in peripheral blood and within myoma tissues

V3-Myoma

Galyna Kutsyna, MD, MD/PhD

Marina Tarakanovskaya, MD

Aldar Bourinbaiar, MD

Galyna Kutsyna, MD

Aldar Bourinbaiar, PhD, MD/PhD

Myoma of the uterus or uterine fibroids are benign tumors that appears in the myometrium or the muscular layer of the uterus. It is one of the most common diseases in pre-climax women, reaching 12-25% of all gynecological diseases. There is an opinion that the true prevalence of myoma is much larger and reaches up to 80%, i.e., practically every second woman has it, often without knowing about. For the treatment of MM, surgical removal of the nodes or removal of the uterus is used. In addition, GnRH-agonist therapy is practiced, as well as embolization to block blood flow in the tumor. We propose to evaluate the immunotherapy approach in an open label Phase II study in 20 women with myoma, for whom no alternative therapy is available.

Myoma or uterine fibroids are one of the most common gynecological diseases, which occurs in at least one third of women older than 35 years, and after 40 - in every second. We will test a new tablet preparation, V3-Myoma, obtained from hydrolyzed, inactivated blood and tumor tissues of patients with uterine myoma. When administered orally, V3-Myoma should cause a specific anti-tumor immune response and an anti-inflammatory effect. Such an effect is due to the phenomenon known in immunology, called oral tolerance, leading to a reduction in tumor mass and a decrease in inflammation. An important advantage of our approach is the absence of any negative side effects. In the next three month, we will conduct Phase II open label clinical study of this intervention in 30 women with confirmed diagnosis of myoma.

Open Label Immunotherapy of Myoma

Open Label Phase II Clinical Trial of Myoma Immunotherapy

Upon study completion the data will be available in peer-reviewed publication

This parameter will be evaluated by pelvic examination and transvaginal ultrasonography

Immunitor LLC

Musculoskeletal Diseases

Nervous System Diseases

Joint Diseases

Contracture

Dupuytren Contracture

Muscular Diseases

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Prednisolone

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Percutaneous needle fasciotomy with corticosteroid injection

Percutaneous needle fasciotomy with saline injection

Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre

Percutaneous needle fasciotomy

Corticosteroid injection

Saline injection

Laura H Matthiesen, MS, PhD-student

Jeppe Lange, MD, PhD

Laura H Matthiesen, PhD Student

Comparing percutaneous needle fasciotomy +/- corticosteroid injection for Dupuytren's contracture affecting metacarpophalangeal joints. A clinician-initiated, multicenter, randomized controlled trial.

Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture

Percutaneous Needle Fasciotomy (PNF) +/- Corticosteroid Injection for Dupuytren's Contracture (DC) Affecting Metacarpophalangeal Joints (MCP) . A Randomized Controlled Trial

Recurrence is defined as 20 degrees or more passive extension deficit in metacarpophalangeal joint from baseline

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficacy of Telapristone Acetate (Proellex®) Administered Vaginally for the Treatment of Uterine Fibroids	NCT02323646	Uterine Fibroid...	Placebo Telapristone Ac...	18 Years - 47 Years	Repros Therapeutics Inc.
Open Label Immunotherapy of Myoma	NCT03550703	Myoma;Uterus Fibroid Uterus Leiomyoma Fibroma	V3-Myoma	18 Years - 65 Years	Immunitor LLC
Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture	NCT05440240	Dupuytren Contr... Dupuytren's Dis... Contracture Joint Diseases Musculoskeletal... Fibroma Neoplasm, Fibro... Neoplasms, Conn... Neoplasms, Conn... Neoplasms by Hi... Neoplasms Connective Tiss...	Percutaneous ne... Corticosteroid ... Saline injectio...	45 Years - 99 Years	Regionshospitalet Silkeborg
Open Label Immunotherapy of Myoma	NCT03550703	Myoma;Uterus Fibroid Uterus Leiomyoma Fibroma	V3-Myoma	18 Years - 65 Years	Immunitor LLC
Safety and Efficacy of Telapristone Acetate (Proellex®) Administered Vaginally for the Treatment of Uterine Fibroids	NCT02323646	Uterine Fibroid...	Placebo Telapristone Ac...	18 Years - 47 Years	Repros Therapeutics Inc.
Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture	NCT05440240	Dupuytren Contr... Dupuytren's Dis... Contracture Joint Diseases Musculoskeletal... Fibroma Neoplasm, Fibro... Neoplasms, Conn... Neoplasms, Conn... Neoplasms by Hi... Neoplasms Connective Tiss...	Percutaneous ne... Corticosteroid ... Saline injectio...	45 Years - 99 Years	Regionshospitalet Silkeborg
Safety and Efficacy of Telapristone Acetate (Proellex®) Administered Vaginally for the Treatment of Uterine Fibroids	NCT02323646	Uterine Fibroid...	Placebo Telapristone Ac...	18 Years - 47 Years	Repros Therapeutics Inc.
Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture	NCT05440240	Dupuytren Contr... Dupuytren's Dis... Contracture Joint Diseases Musculoskeletal... Fibroma Neoplasm, Fibro... Neoplasms, Conn... Neoplasms, Conn... Neoplasms by Hi... Neoplasms Connective Tiss...	Percutaneous ne... Corticosteroid ... Saline injectio...	45 Years - 99 Years	Regionshospitalet Silkeborg

Spots Global Cancer Trial Database for fibroma

Every month we try and update this database with for fibroma cancer trials from around the world to help patients and their families find trials that might be right for them.
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.

Spots Global Cancer Trial Database for fibroma

Every month we try and update this database with for fibroma cancer trials from around the world to help patients and their families find trials that might be right for them. 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.

Every month we try and update this database with for fibroma cancer trials from around the world to help patients and their families find trials that might be right for them.
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.