Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Leiomyoma

Myofibroma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

All Drugs and Chemicals

Antineoplastic Agents

Reproductive Control Agents

Hormones

Leuprolide

Ulipristal acetate

Contraceptive Agents

Contraceptive Agents, Hormonal

Contraceptive Agents, Female

11.25 mg Leuproreline injections at the onset of pretreatment with placebo tablets (once daily)

Three months of Ulipristal 5 mg once daily combined with a single saline injection at the onset of pretreatment (produced as placebo of Leuproreline)

No pre-treatment prior to laparoscopic myomectomy

GnRHa

Ulipristal

Inge de Milliano, MD

Marchien van Baal

P Van Kesteren

Andreas Thurkow

Wouter Hehenkamp, PhD

D Schoot

Jonas van de Lande

Sjors Coppus

M Aktas

M Bongers

Rationale: Laparoscopic myomectomy is increasingly performed over laparotomic myomectomy, because of the many benefits for the patient in terms of pain, hospital stay and recovery. In order to increase the success rate of a laparoscopic procedure pre-treatment to decrease the volume might be beneficial. Gonadotropin-releasing hormone agonists (GnRHa) are used for this purpose with good results in terms of volume reduction, but sometimes resulting in loss of distinction of the right surgical planes. Ulipristal is a new pre-operative treatment option for symptomatic fibroids, which has demonstrated good results in terms of volume reduction. The effect on cleavage planes is unknown. This study is performed to evaluate if Ulipristal is as effective as GnRHa in terms of surgical outcome.

Objective: to investigate if Ulipristal is non-inferior to GnRH in terms of intra-operative blood-loss (primary outcome), surgical time, surgical ease, complications, quality of life and costs.

Study design: Double blind randomized controlled multi-center trial. Study population: Premenopausal women in whom a maximum of 2 symptomatic intramural fibroids between 5 and 12 cm in diameter will be removed. Fibroid types 3, 4, 5, 6 and 2-5 will be included.

Intervention: Three months of Ulipristal 5 mg once daily combined with a single saline injection at the onset of pretreatment (produced as placebo of Leuproreline) or (comparison) 11.25 mg Leuproreline injections at the onset of pretreatment with placebo tablets (once daily) .

Methods: Within 1 month after pre-treatment patients will undergo a laparoscopic myomectomy by experienced surgeons. Operative characteristics will be recorded prospectively. Follow up will be 6 months after surgery mainly for quality of life assessment. A cost utility analysis will be conducted alongside the trial.

Main study parameters/endpoints: Ulipristal is non-inferior to GnRHa in terms of blood loss during surgery when the average difference between the two groups is below 150 ml (standard deviation 250 ml).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Both Ulipristal and GnRHa have been registered for this indication. Safety has been tested and no specific risks apply.

Ulipristal vs. GnRHa Prior to Laparoscopic Myomectomy

Ulipristal Versus Gonadotropin-releasing Hormone Agonists Prior to Laparoscopic Myomectomy: a Double Blind Randomized Controlled Trial

Ulipristal is non-inferior to GnRHa in terms of blood loss during surgery when the average difference between the two groups is below 150 ml (standard deviation 250 ml)

Amsterdam UMC, location VUmc

Breast Neoplasms

Breast Diseases

Skin Diseases

Goserelin

Antineoplastic Agents, Hormonal

Eligible patients with breast cancer treated with GnRHa while receiving chemotherapy.

Eligible patients with breast cancer treated without GnRHa while receiving chemotherapy.

3.6mg subcutaneous injection every 28 days.Initiated 1-2 weeks before chemotherapy and ended 4-8 weeks after chemotherapy.

XIANGYUN ZONG, MD, PhD

This prospective randomized controlled study is conducted to analyze the effect of Goserelin on ovarian function in women with breast cancer in China.

Effects of GnRHa on Ovarian Function Against Chemotherapy-induced-gonadotoxicity

Effects of GnRHa on Ovarian Function Against Chemotherapy-induced-gonadotoxicity in Women With Breast Cancer in China

The serum levels of anti-Müllerian hormone (AMH) were measured using human AMH ELISA kit (11351, Biofine)). POI (premature ovarian insufficiency) was defined as AMH\<0.5ng/mL in this study.

Zhejiang Cancer Hospital

Xiangyun Zong

Chief

Eligible patients with breast cancer treated with GnRHa while receiving chemotherapy.

GnRHa: 3.6mg subcutaneous injection every 28 days.Initiated 1-2 weeks before chemotherapy and ended 4-8 weeks after chemotherapy.

GnRHa Group

None GnRHa Group

Eligible patients with breast cancer treated with Gonadotrophin-releasing hormone analogues （GnRHa） while receiving chemotherapy.

Goserelin 3.6mg, or leuprorelin 3.75mg subcutaneous injection every 28 days.Initiated 1-2 weeks before chemotherapy and ended 4-8 weeks after chemotherapy.

GnRHa (Gonadotrophin-releasing Hormone Analogues) Group

None GnRHa (Gonadotrophin-releasing Hormone Analogues) Group

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

CHINA

Race/Ethnicity, Customized

China

Region of Enrollment

anti-Müllerian hormone (AMH)

Dr. ZONG

Eligible patients with breast cancer treated with GnRHa (Gonadotrophin-releasing Hormone Analogues) while receiving chemotherapy.

Goserelin 3.6mg, or leuprorelin 3.75mg subcutaneous injection every 28 days.Initiated 1-2 weeks before chemotherapy and ended 4-8 weeks after chemotherapy.

Eligible patients with breast cancer treated without GnRHa (Gonadotrophin-releasing Hormone Analogues) while receiving chemotherapy.

Number of Participants With Premature Ovarian Insufficiency

Survival Rate

Overall Study

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Respiratory Tract Infections

Myoma

Neoplasms, Connective Tissue

Connective Tissue Diseases

Triptorelin Pamoate

triptorelin 3.75 mg, im, monthly, three times

Triptorelin 3.75 mg

sandro gerli, MD

The primary outcome of this study is to assess if the GnRHa administration before cold loop hysteroscopic myomectomy contributes to accomplish the treatment in only one surgical procedure. Moreover, we will investigate the intraoperative influence of such pharmacologic therapy in terms of distension liquid absorption and duration of the procedures.

GnRH Agonist Pretreatment in Hysteroscopic Myomectomy

Surgical Effects of GnRH Agonist Pretreatment on Cold Loop Hysteroscopic Myomectomy.

Azienda Ospedaliera S. Maria della Misericordia

Assistant Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Endometrial Neoplasms

Hyperplasia

Endometrial Hyperplasia

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Hypoglycemic Agents

Metformin

Letrozole

Progestins

Ethinyl Estradiol

Cyproterone Acetate

Cyproterone

Estradiol 17 beta-cypionate

Estradiol 3-benzoate

Estradiol

Polyestradiol phosphate

Cyproterone acetate, ethinyl estradiol drug combination

Aromatase Inhibitors

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Contraceptives, Oral

Contraceptives, Oral, Hormonal

Androgens

Androgen Antagonists

20 non-obese EEC patients will be randomized to GnRHa + Letrozole group.Then every 12 weeks, an hysteroscope will be used to evaluate the endometrial condition, and the pathological findings will be recorded.

20 non-obese EEC patients will be randomized to Diane-35 + metformin group.Then every 12 weeks, an hysteroscope will be used to evaluate the endometrial condition, and the pathological findings will be recorded.

20 non-obese EAH patients will be randomized to GnRHa + Letrozole group.Then every 12 weeks, an hysteroscope will be used to evaluate the endometrial condition, and the pathological findings will be recorded.

20 non-obese EAH patients will be randomized to Diane-35 + metformin group.Then every 12 weeks, an hysteroscope will be used to evaluate the endometrial condition, and the pathological findings will be recorded.

Gonadotropin-releasing hormone analogue, intramuscular injection of 3.75mg will be given every 4 weeks , and the maximum using courses will be 6.

Letrozole 2.5mg

Periodic use. Patients will receive one pill po qd for 21 days, and next period should be started after 7 days.

Diane-35

Xiaojun Chen, PhD

Bingyi Yang

Bingyi Yang, MD

Xiaojun Chen

Pengfei Wu

To investigate the efficacy of GnRHa plus letrozole vs Diane-35 plus metformin in non-obese progestin-insensitive early-stage endometrial cancer (EEC) and atypical hyperplasia(EAH) patients asking for conservative treatment.

There were more and more women with early endometrioid endometrial cancer (EEC) and atypical endometrial hyperplasia (EAH) who want to preserve fertility. Approximately 70% to 80% of females who meet the criteria for conservation treatment are able to achieve CR after progestin therapy, with a median time of 6-7 months, but about 20% to 30% of patients get no response or need to take longer time to achieve remission (over one year). With long duration of treatment, there will be more side effects such as weight gain, impaired liver function, endometrial injury, ovarian reserve inhibition etc. which will decrease the efficacy of conservative treatment. Previous researches had shown that GnRHa plus letrozole or ethinylestradiol cyproterone plus metformin could be a better second-line treatment for progestin-insensitive patients. Till now, no similar studies were found, so we design this study to explore the efficacy of GnRHa plus letrozole and ethinylestradiol cyproterone plus metformin in progestin-insensitive EEC and EAH patients to provide new evidences for improving conservative treatment efficacy. Considered there will be more thrombotic risks in obese patients using ethinylestradiol cyproterone, we enrolled patients with BMI \< 30kg/m2 only in this study.

This will be a single-centred prospective pilot study. Patients diagnosed as progestin-insensitive EAH or EEC by dilatation and curettage (D\&C) or hysteroscopy will be enrolled. Non-obese patients will be stratified by pathological diagnosis (EEC or EAH) and then they will be randomly assigned (1:1) to two arms. One will be GnRHa + letrozole group and another will be ethinylestradiol cyproterone + metformin group.

The primary endpoint is cumulative complete response (CR) rate at 28 weeks of treatment. The secondary endpoints include adverse events, duration of complete response, recurrent rate, pregnancy rate and quality of life of patients.

GnRHa + Letrozole in Non-obese Progestin-insensitive Endometrial Cancer and Atypical Hyperplasia Patients

Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole in Non-obese Progestin-insensitive Early-stage Endometrial Cancer and Atypical Hyperplasia Patients With Conservative Treatment

The cumulative 28-week CR rates will be calculated in two groups. Patients will be evaluated with an hysteroscopy every 12 weeks. For some may delay the evaluation as personal reasons, we define the primary outcome measure as complete response rates within 28 weeks of treatment.

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 will be recorded, as well as incidence of adverse events.

The median CR time will be calculated in two groups

Professor

Behaviors and Mental Disorders

Quality of Life

Menopause

This was a real world, observational study of adjuvant endocrine therapy with GnRHa for OFS in postoperative, premenopausal women with endocrine responsive breast cancer. Patients will receive treatment per GnRHa commercial label instruction: leuprorelin, goserelin, leuprorelin from local like: acetate microspheres sustained for injection(boennuokang), leuprorelin acetate microspheres for injection(beiyi).

3M GnRHa

1M GnRHa

Lei Fan

The purpose of this study is to assess the patient's feedback from using GnRHa depot formulation in postoperative, premenopausal patients with hormone receptor-positive breast cancer.

This was a real world, observational study of adjuvant therapy with GnRHa for OFS in postoperative, premenopausal women with endocrine responsive breast cancer. This trial is designed to compare patients' QOL and treatment compliance measured by FACT-B and self-administered questionnaires during OFS treatment period. Total score of FACT-B and self-administered questionaries, and change from baseline will be calculated and summarized descriptively. Change from baseline will be compared between GnRHa 3-month and GnRHa 1-month using ANCOVA model with baseline value as a covariate.The number depends on the patients who received questionnaire during 18 months recruitment in planned 10 sites. This analytical plan assumes homogeneity across 10 sites so that strata is not considered.

RWE About QOL and Compliance of Patients With OFS in China

QoL and Treatment Compliance for Pre-menopausal Patients With HR+ Breast Cancer Using GnRHa as Ovarian Function Suppression(OFS) Treatment in the Chinese Population: a Real-world Observational Investigation

QOL of participant will be measured by Functional Assessment of Cancer Therapy -Breast (FACT-B) questionnaires, a 37-item instrument designed to measure five domains of QOL in breast cancer patients. Score range: 0-148. The score includes forward items (the higher score means the better of quality of life) and the reverse items (the higher score means the worse quality of life).

Treatment compliance will be measured by self-administered questionnaire. Scale score range: 0-40. The score includes forward items (the higher score means the better adherence) and the reverse items (the higher score means the worse adherence).

Fudan University

Professor Shao

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ulipristal vs. GnRHa Prior to Laparoscopic Myomectomy	NCT02288130	Fibroids	GnRHa Ulipristal	18 Years -	Amsterdam UMC, location VUmc
Effects of GnRHa on Ovarian Function Against Chemotherapy-induced-gonadotoxicity	NCT02518191	Breast Cancer	GnRHa	18 Years - 49 Years	Shanghai Jiao Tong University Affiliated Sixth People's Hospital
GnRH Agonist Pretreatment in Hysteroscopic Myomectomy	NCT01873378	Uterine Myoma	Triptorelin 3.7...	18 Years - 55 Years	Azienda Ospedaliera S. Maria della Misericordia
GnRHa + Letrozole in Non-obese Progestin-insensitive Endometrial Cancer and Atypical Hyperplasia Patients	NCT05316935	Endometrial Neo... Atypical Endome... Progesterone Re...	GnRHa Letrozole 2.5mg Diane-35 MET	18 Years - 45 Years	Fudan University
RWE About QOL and Compliance of Patients With OFS in China	NCT05122377	Breast Cancer Quality of Life Hormone Recepto...	3M GnRHa 1M GnRHa	18 Years -	Fudan University
Ulipristal vs. GnRHa Prior to Laparoscopic Myomectomy	NCT02288130	Fibroids	GnRHa Ulipristal	18 Years -	Amsterdam UMC, location VUmc
GnRHa + Letrozole in Non-obese Progestin-insensitive Endometrial Cancer and Atypical Hyperplasia Patients	NCT05316935	Endometrial Neo... Atypical Endome... Progesterone Re...	GnRHa Letrozole 2.5mg Diane-35 MET	18 Years - 45 Years	Fudan University

Spots Global Cancer Trial Database for gnrha

Every month we try and update this database with for gnrha 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 gnrha

Every month we try and update this database with for gnrha 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 gnrha 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.