Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Leiomyoma

Myofibroma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

Coagulants

All Drugs and Chemicals

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Reproductive Control Agents

Mineral

Tranexamic Acid

Chrysarobin

Progesterone

Ulipristal acetate

Antifibrinolytic Agents

Hemostatics

Contraceptive Agents

Contraceptive Agents, Hormonal

Contraceptive Agents, Female

Iron Supplement

Patients will be prescribed Ulipristal acetate 5mg daily for 12 weeks before operation. If the patients have anaemia with haemoglobin less than 10g/dL, ferrous sulphate 300mg three times a day will be prescribed as well. Tranexamic Acid 500mg four times a day will be prescribed on request basis.

Patients will be prescribed placebo pills daily for 12 weeks before operation. If the patients have anaemia with haemoglobin less than 10g/dL, ferrous sulphate 300mg three times a day will be prescribed as well. Tranexamic Acid 500mg four times a day will be prescribed on request basis.

Ulipristal acetate 5mg daily will be prescribed

Placebo pills

Ferrous sulphate 300mg three times a day will be prescribed if haemoglobin level is less than 10g/dL.

Ferrous sulphate

Tranexamic Acid 500mg four times a day on request basis will be prescribed if patient complained of menorrhagia.

Ernest H. Y. Ng

Uterine leiomyomas is the commonest benign tumour of the female genital tract. It lead to menorrhagia, anaemia, pain and pressure symptoms. Due to the enlarged uterus, the use of minimal invasive surgery is limited. There is also increase risk of intraoperative blood transfusion. Ulipristal acetate (UPA) is a selective progesterone-receptor modulator (SPRM). Preoperative use of Ulipristal for 12 weeks has been shown to decrease uterine bleeding, fibroid volume, pre-operative anaemia and symptoms severity. However there is still lacking evidence in terms of long term safety and efficacy, especially in Chinese population. The aim of the present study is to evaluate the effect and safety on preoperative use of Ulipristal on fibroid.

Uterine leiomyomas is the commonest benign tumour of the female genital tract. It is often asymptomatic, but can also lead to anaemia, pain and pressure symptoms. It is the commonest indication for hysterectomy, especially abdominal hysterectomy. Currently, the use of hormonal treatment is associated with side effects including gastrointestinal upset, bloating, weight gain and thromboembolic risks. The main stay for treatment relies on surgery.

Furthermore, the use of minimal invasive surgeries is limited by the size of the fibroids. Preoperative use of Gonadotrophic Releasing Hormone analogues (GnRHa) is effective in shrinkage of the uterine leiomyomas and reduction of uterine bleeding. However, postmenopausal symptoms including hot flushes, vaginal dryness are profound.

Ulipristal acetate (UPA), previously named CDB-2914, is a selective progesterone-receptor modulator (SPRM). It binds to the progesterone receptors with high affinity. It inhibits follicular development and ovulation, while it has no significant effects on estradiol levels and antiglucocorticoid activity. Preoperative use of Ulipristal for symptomatic uterine fibroids has been investigated in randomized controlled study with improvement in terms of uterine bleeding, fibroids volume, pre-operative anaemia and symptoms severity. However there is still lacking evidence in terms of long term safety and efficacy. Also there is lack of evidence in Chinese population.

The aim of the present study is to evaluate the effect and safety on preoperative use of Ulipristal on fibroid.

Ulipristal Use in Chinese Population

Pilot Study on the Pre-operative Use of Ulipristal on Fibroid in Chinese Population

This is to protect the privacy of individual patients

Pictorial bleeding assessment chart will be used for assessment of uterine bleeding. Patients will be assessed before the start of treatment, after completion of 6 weeks course and after completion of 12 weeks course. The change of uterine bleeding after completion of 12 weeks course of treatment will be recorded.

The change of haemoglobin level after completion of 12 weeks course will be recorded.

The fibroid volume will be measured using ultrasonography before start of treatment, after 6 weeks course of treatment and after completion of 12 weeks course of treatment.

The amount of blood loss at hysterectomy will be recorded.

2 weeks before scheduled operation, patients will be assessed by the operation team and the most suitable route of hysterectomy will be discussed again. The possibility of conversion to less invasive intervention options including from laparotomy to laparoscopy will be recorded.

The side effects including nausea, vomiting, headache, dyspepsia will be recorded.

Presence of malignancy or hyperplasia in the operative specimen will be recorded.

Queen Mary Hospital, Hong Kong

Symptoms and General Pathology

Immune System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Syndrome

Hypersensitivity

Polycystic Ovary Syndrome

Insulin Resistance

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Hyperinsulinism

Metabolic Diseases

Glucose Metabolism Disorders

Micronutrients

Hypoglycemic Agents

Bone Density Conservation Agents

Vitamins

Insulin

Insulin, Globin Zinc

Vitamin D

Cholecalciferol

Ergocalciferols

Trace Elements

Hormones

Calcium

Calcium, Dietary

Vitamin D3

Calciferol

Ergocalciferol

Vitamin D2

Vitamin D3 (cholecalciferol) supplementation (50,000 IU/week for 8 weeks) followed by 1000 IU/day for 16 weeks

Placebo pills will be given 1 per week for 8 weeks followed by 1 per day for 16 weeks

Vitamin D3 pills

Placebo pills similar in appearance and shape but without vitamin D

Mohammed-Salleh M Ardawi, PhD, FRCPath

Abdulrahim A Rouzi, FRCPC

Veronica B Orbacedo, BSc

Ramia Al-sobhi, BSc

Ahmed Y Ali, MD

Ghazi Y Refai, MD

Mohammed H Qari, FRCPA

Heba S Kary, MD

The study tests the hypothesis that correction of vitamin D deficiency among women with PCOS will improve insulin sensitivity and resistance and inflammatory response to PCOS.

Polycystic ovary syndrome (PCOS) is a common complex and heterogenous endocrine disorder. It affects ≤10% of women of reproductive age, with approximately 16%-80% of the affected women being obese. Polycystic ovary syndrome frequently is associated with insulin resistance (IR) accompanied by compensatory hyperinsulinemia, and IR is aggravated by the interaction between obesity and the syndrome. Moreover, the contribution of body mass and/or body fat distribution to IR of PCOS remains controversial. In addition, women with PCOS with IR are at an increased risk of developing diabetes, hypertension, dyslipidemia and atherosclerosis. Preliminary data on the local women with PCOS showed high prevalence of vitamin D deficiency (serum 25(OH)D \< 50 nmol/L). Recent studies showed that vitamin D deficiency is linked to IR, type 2 diabetes mellitus, obesity, inflammation and cardio vascular disease. Several studies have demonstrated that serum 25(OH)D levels were negatively correlated with body mass index (BMI), body fat, and IR. These conditions are common among women with PCOS. Accordingly, it is anticipated that vitamin D deficiency and/or insufficiency may contribute to the endocrine and metabolic disarrangements among women with PCOS. Such adverse effects may further contribute to the risk of further long term complications among women with PCOS.

Vitamin D Status in Relation to Insulin Sensitivity Among Saudi Women With Polycystic Ovary Syndrome

Vitamin D Status in Relation to Insulin Sensitivity, Resistance and Inflammatory Response Among Saudi Women With Polycystic Ovary Syndrome

Other endpoints were changes in inflammatory markers (hs-CRP)

Other endpoints were changes in lipid profile (total cholesterol, HDL-c, LDL-c, and triglycerides)

Other endpoints were changes in liver function tests \[albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase(ALP)\]; renal function tests (cystatine C, uric acid, urea) and parathyroid hormone (PTH)

Other endpoints were changes in HbA1c, fasting plasma glucose and fasting plasma insulin

Other endpoints were changes in serum 25-hydroxyvitamin D

Other endpoints were changes in (follicle-stimulating hormone, luteinizing hormone, prolactin, thyroid-stimulating hormone, free thyroxine, total testosterone, dehydroepiandrosterone (DHEA), DHEA sulfate, delta 4-androstenedione and sex-hormone binding globulin).

The primary endpoint was an improvement in insulin resistance parameters \[Fasting serum insulin,glucose-to-insulin ratio (GIR) and homeostasis model assessment (HOMA) \] from baseline and at 24 weeks in vitamin D supplemented as compared with placebo groups.

Secondary endpoints were changes in parameter of insulin sensitivity\[ quantitative insulin sensitivity check index (QUICKI)\], among vitamin D supplemented group vs placebo group from baseline and at the end of the trial

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Ulipristal Use in Chinese Population	NCT02825719	Fibroid	Ulipristal acet... Placebo pills Ferrous sulphat... Tranexamic Acid	18 Years -	Queen Mary Hospital, Hong Kong
Vitamin D Status in Relation to Insulin Sensitivity Among Saudi Women With Polycystic Ovary Syndrome	NCT02164552	Polycystic Ovar...	Vitamin D3 pill... Placebo pills	20 Years - 45 Years	King Abdulaziz University

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