Ignite Creation Date:
2024-05-06 @ 12:27 AM
Last Modification Date:
2024-10-26 @ 10:50 AM
Study NCT ID:
NCT01588873
Status:
UNKNOWN
Last Update Posted:
2012-05-04
First Post:
2012-03-28
Brief Title:
Contraceptive Pill and Hormonal Vaginal Ring in Women With Polycystic Ovary Syndrome
Sponsor:
University of Oulu
Organization:
University of Oulu
Study Overview
Official Title:
The Effects of Contraceptive Pill and Hormonal Vaginal Ring on Hormonal Inflammatory and Metabolic Parameters in Women of Reproductive Age With Polycystic Ovary Syndrome PCOS
Status:
UNKNOWN
Status Verified Date:
2012-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main aims of this study are
to investigate and compare the effects of long lasting use 59 weeks of vaginal and oral contraceptives on androgen secretion insulin and glucose metabolism lipid profile and serum levels of SHBG and hs-CRP in women with PCOS
to compare the metabolic effects of oral and vaginal combined contraceptives and to find out whether oral or transvaginal contraceptive can be recommended to a particular group of women for example in women with increased metabolic risks
to clarify whether the unfavourable effects of combined contraceptives diminish with time after use of one year
to investigate and compare the effects of long lasting use 59 weeks of vaginal and oral contraceptives on androgen secretion insulin and glucose metabolism lipid profile and serum levels of SHBG and hs-CRP in women with PCOS
to compare the metabolic effects of oral and vaginal combined contraceptives and to find out whether oral or transvaginal contraceptive can be recommended to a particular group of women for example in women with increased metabolic risks
to clarify whether the unfavourable effects of combined contraceptives diminish with time after use of one year
Detailed Description:
The study population consists of women of reproductive age with PCOS no wish of pregnancy and no other contraindications to hormonal contraceptives
The volunteer subjects will be recruited from hospitals patient files with PCOS IC diagnosis E282
Methods Sample size Our previous study comparing the metabolic effects of the same preparations Mercilon and Nuvaring in young healthy women shown an significant decrease of 165 SD 168in the Matsuda index at 9 weeks of treatment with oral contraceptive pill Power analysis indicated that 14 women would be needed in both groups to reveal a similar significant decrease in the serum level of Matsuda index To allow for drop-outs estimated to be as high as 20-30 the planned sample size will be 21 in each group
Medication Forty women will be randomised either to the pill n21 or ring n21 group The OC or contraceptive ring will be used in nine weeks periods Every period will be followed by a break of one week
In the pill group the subjects start the pill during the first days of the follicular phase of the cycle after the baseline examinations and continue nonstop for nine weeks ie until the third package has ran out This is followed by one weeks break The ring is replaced every three weeks and the treatment is continued nine weeks after which one week break follows In both groups the cycle will be repeated six times resulting in 59 weeks of treatment
The used preparations are Vaginal ring depotproduct ethinylestradiol 27 mg 0015 mgday and etonogestrel 117 mg 0120 mgdayand the contraceptive pill ethinylestradiol tabl 20 µg desogestrel 150 µg
Ultrasonography An ultrasonography of the ovaries will be performed at baseline to support the diagnosis of PCOS and exclude any androgen releasing tumors
Blood samples Blood samples for hormonal and metabolic assessments will be taken at every appointment
Oral glucose tolerance test OGTT The glucose metabolism and tolerance are measured with an oral glucose tolerance test where the subjects take a dose of 75 grams of glucose mixed in 300ml of water after ten hours fasting The blood samples are taken before the test and 30 60 and 120 minutes after the glucose intake
The schedule A wash-out period of at least 2 months after the use of any previous hormonal contraceptives will be required At baseline all examinations are performed at the 1st to 5th day of the menstruation cycle before beginning contraception
The second appointment will occur during the 9th pillring week the third at the 29th week the fourth at the 59th week and the last appointment one month after stopping contraception Blood samples are taken and blood pressure is measured at every appointment OGTT will be performed at every appointment except at the 29th week
Serum analyses All blood samples will be collected in the morning between 07 and 10 after an overnight fast and during the follicular phase cycle days 1-4 or at any time in cases of amenorrhea All screening analyses will be analysed at the local hospital
Seven test-tubes whole blood are collected from each patient Six tubes are centrifuged within 30 minutes and serum is filled in eight 8 tubes with at least 2 ml of serum in each and immediately frozen at -70 º C In addition the plasma from one tube will frozen at -70 º C in at least 2 tubes with at least 2ml plasma in each Every tube is marked by randomisation number initials date of birth and time
Fasting plasma glucose and HbA1c will be analysed at once at every appointment at the local hospital
Planned analyses Hormonal metabolic and inflammatory parameters Ethical questions and possible harmful effects Participating in the research is completely voluntary When taking the blood samples the risks are practically restricted to the problems caused by the stitch of the needle
The possible adverse effects of the used contraceptives are observed at every appointment Problems are reported to FIMEA Finnish Medical Association and to the local ethical committee if necessary
A continuous dosing is used in this study which is not routine treatment Uninterrupted dosing of contraceptive pills has been used in several studies and no differences in the contraceptive effect compared to routine dosing have been reported Instead the menstruation comes less frequently which is user-friendly Continuous dosing may cause slightly more swelling and extra leakage
After the study the treatment of the subjects continues following standard practice
All information required will be kept locked in cupboards and disposed ten years after the study has ended Information on computer requires username and password
Analysing the results and their significance Blood samples are analyzed in Oulu University Hospital laboratory of Clinical Chemistry which fulfills international quality criteria The results are analyzed using SPSS-program During the research Oulu University statistics-professional will be consulted for help in the statistical analyses
Significance of the study
This study will allow to clarify whether oral or transvaginal contraceptive can be recommended to a particular group of women for example in women with increased metabolic risks It will also clarify whether the unfavourable effects of combined contraceptives decrease after long term use
Concealment and disposing the register The information and study data will be kept on computer requiring a username and password All written information will be kept in a room in locked cupboards The register will be disposed following ethical committees instructions no later than the end of 2027
Schedule The study will begin in spring 2012 and is estimated to continue until December 2018
Funding The study will be funded by the Sigrid Juselius organization and from the Kevo-fund of Department of Obstetrics and Gynaecology of Oulu University Hospital
Changes in the plan Every possible changes in the study design will be reported to the local Ethical Committee
The volunteer subjects will be recruited from hospitals patient files with PCOS IC diagnosis E282
Methods Sample size Our previous study comparing the metabolic effects of the same preparations Mercilon and Nuvaring in young healthy women shown an significant decrease of 165 SD 168in the Matsuda index at 9 weeks of treatment with oral contraceptive pill Power analysis indicated that 14 women would be needed in both groups to reveal a similar significant decrease in the serum level of Matsuda index To allow for drop-outs estimated to be as high as 20-30 the planned sample size will be 21 in each group
Medication Forty women will be randomised either to the pill n21 or ring n21 group The OC or contraceptive ring will be used in nine weeks periods Every period will be followed by a break of one week
In the pill group the subjects start the pill during the first days of the follicular phase of the cycle after the baseline examinations and continue nonstop for nine weeks ie until the third package has ran out This is followed by one weeks break The ring is replaced every three weeks and the treatment is continued nine weeks after which one week break follows In both groups the cycle will be repeated six times resulting in 59 weeks of treatment
The used preparations are Vaginal ring depotproduct ethinylestradiol 27 mg 0015 mgday and etonogestrel 117 mg 0120 mgdayand the contraceptive pill ethinylestradiol tabl 20 µg desogestrel 150 µg
Ultrasonography An ultrasonography of the ovaries will be performed at baseline to support the diagnosis of PCOS and exclude any androgen releasing tumors
Blood samples Blood samples for hormonal and metabolic assessments will be taken at every appointment
Oral glucose tolerance test OGTT The glucose metabolism and tolerance are measured with an oral glucose tolerance test where the subjects take a dose of 75 grams of glucose mixed in 300ml of water after ten hours fasting The blood samples are taken before the test and 30 60 and 120 minutes after the glucose intake
The schedule A wash-out period of at least 2 months after the use of any previous hormonal contraceptives will be required At baseline all examinations are performed at the 1st to 5th day of the menstruation cycle before beginning contraception
The second appointment will occur during the 9th pillring week the third at the 29th week the fourth at the 59th week and the last appointment one month after stopping contraception Blood samples are taken and blood pressure is measured at every appointment OGTT will be performed at every appointment except at the 29th week
Serum analyses All blood samples will be collected in the morning between 07 and 10 after an overnight fast and during the follicular phase cycle days 1-4 or at any time in cases of amenorrhea All screening analyses will be analysed at the local hospital
Seven test-tubes whole blood are collected from each patient Six tubes are centrifuged within 30 minutes and serum is filled in eight 8 tubes with at least 2 ml of serum in each and immediately frozen at -70 º C In addition the plasma from one tube will frozen at -70 º C in at least 2 tubes with at least 2ml plasma in each Every tube is marked by randomisation number initials date of birth and time
Fasting plasma glucose and HbA1c will be analysed at once at every appointment at the local hospital
Planned analyses Hormonal metabolic and inflammatory parameters Ethical questions and possible harmful effects Participating in the research is completely voluntary When taking the blood samples the risks are practically restricted to the problems caused by the stitch of the needle
The possible adverse effects of the used contraceptives are observed at every appointment Problems are reported to FIMEA Finnish Medical Association and to the local ethical committee if necessary
A continuous dosing is used in this study which is not routine treatment Uninterrupted dosing of contraceptive pills has been used in several studies and no differences in the contraceptive effect compared to routine dosing have been reported Instead the menstruation comes less frequently which is user-friendly Continuous dosing may cause slightly more swelling and extra leakage
After the study the treatment of the subjects continues following standard practice
All information required will be kept locked in cupboards and disposed ten years after the study has ended Information on computer requires username and password
Analysing the results and their significance Blood samples are analyzed in Oulu University Hospital laboratory of Clinical Chemistry which fulfills international quality criteria The results are analyzed using SPSS-program During the research Oulu University statistics-professional will be consulted for help in the statistical analyses
Significance of the study
This study will allow to clarify whether oral or transvaginal contraceptive can be recommended to a particular group of women for example in women with increased metabolic risks It will also clarify whether the unfavourable effects of combined contraceptives decrease after long term use
Concealment and disposing the register The information and study data will be kept on computer requiring a username and password All written information will be kept in a room in locked cupboards The register will be disposed following ethical committees instructions no later than the end of 2027
Schedule The study will begin in spring 2012 and is estimated to continue until December 2018
Funding The study will be funded by the Sigrid Juselius organization and from the Kevo-fund of Department of Obstetrics and Gynaecology of Oulu University Hospital
Changes in the plan Every possible changes in the study design will be reported to the local Ethical Committee
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None