Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS) (EMDPCOS)
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|ClinicalTrials.gov Identifier: NCT03652987|
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : April 12, 2019
|Condition or disease|
|Polycystic Ovary Syndrome Insulin Resistance Vitamin D Deficiency Obesity|
Women are referred by the general practioner (GP)/primary care with a suspected diagnosis of PCOS to the Endocrine Clinic at St George's Hospital.
They have an initial routine clinical assessment involving history, BP, weight & assessment of PCOS using the Rotterdam criteria.
The routine clinical investigations involve the following:
• one fasting blood sample to measure various hormones; fasting glucose:insulin ratio; pelvic ultrasound scan to determine ovarian morphology, follicular count and endometrial thickness
Part 1 of the research protocol will include obtaining the following:
- One urine & serum sample to be taken at the same time as their routine clinical blood samples.
- These samples will be anonymised before despatch to SPD. Part 2 of the study will involve treating patients with Vitamin D (if they are deficient) and/or myo-inositol supplement or metformin depending on their clinical need. The outcomes measured will be as above (blood sample to measure hormones) and an assessment of body fat distribution.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||300 participants|
|Target Follow-Up Duration:||6 Months|
|Official Title:||Evaluation of Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS): Impact of Weight, Metabolic Status, Age and Ethnicity.|
|Actual Study Start Date :||September 5, 2018|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||September 2023|
- Assay measurements of hormones in blood and urine samples i.e. testosterone, SHBG, FSH, LH, VD, AMH, fasting insulin & glucose. [ Time Frame: 6 months ]Statistically significant differences in: levels of hormone/factors produced as measured in blood and urine samples sent to pathology lab; hormonal & metabolic responses/parameters after dietary/pharmaceutical intervention
- Measurement of BMI [ Time Frame: 6 months ]BMI between different patient types
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652987
|Contact: Suman Rice, PhDemail@example.com|
|Contact: Nadia Azzouzi||020 8266 firstname.lastname@example.org|