The Effect of Hormonal Contraception on Female (HORMCONTRA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01852786|
Recruitment Status : Unknown
Verified May 2013 by Lina Ciaplinskiene, Lithuanian University of Health Sciences.
Recruitment status was: Active, not recruiting
First Posted : May 14, 2013
Last Update Posted : May 14, 2013
The aim- To evaluate the impact of combined oral contraceptives on women's psychosexual, metabolic, blood coagulation, hormonal and genetic measures.
Combined oral contraceptives (COCs) is still the most popular contraception method. It is possible to find a number of publications about their non-contraceptive benefits, also about their adverse events. Most researches are conducted during clinical trials, which are commissioned by pharmaceutical companies, in order to compare COCs of different composition. This study set out to assess the role of psychosexual, metabolic, endocrine, hormonal and genetic measures of low dose combined oral contraceptive users- 20 micrograms of Ethinylestradiol/3 mg of Drospirenone and 20 micrograms of Ethinylestradiol/75 micrograms of Gestoden. Because this study is not commercial, it is expected to obtain valuable objective data - there are very few comparative studies about the impact of COCs to woman's organism.
|Condition or disease||Intervention/treatment|
|Adverse Effect of Oral Contraceptives, Initial Encounter||Other: Contraceptives, Oral, Combined Other: Controls|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||340 participants|
|Observational Model:||Case Control|
|Official Title:||Metabolic, Androgen, Blood Coagulation Parameters and Female Sexual Function in Relation to Oral Contraceptive Use and Androgen Receptor Polymorphisms in Healthy Lithuanian Women|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||February 2015|
|Estimated Study Completion Date :||February 2016|
Contraceptives, Oral, Combined
The women, presenting for hormonal contraception use and with no contraindications for hormonal therapy.
Other: Contraceptives, Oral, Combined
• The women, presenting for hormonal contraception use and with no contraindications for hormonal therapy, one of the two medicines registered in Lithuania will be administered׃ Daylette (20 micrograms of Ethinylestradiol and 3 mg of Drospirenone) or Lindynette (20 micrograms of Ethinylestradiol and 75 micrograms of Gestoden).
Other Name: COMBINED ORAL CONTRACEPTIVES
The women, presenting for non- hormonal contraception- barrier contraception methods -BCM- or natural family planning methods- NFPM.
The women, The women presenting for non-hormonal contraception use, will be recommended BCM or NFPM.
Other Name: NATURAL FAMILY PLANNING
- Hirsutism [ Time Frame: 2 years ]The expression of terminal hair growth using Ferriman- Gallwey scoring system in Lithuanian women will be assessed.
- Blood coagulation parameters and hormonal contraception [ Time Frame: 3 years ]Blood coagulation parameters in six month period will be measured. The risk for development of thromboembolic complications for COCs use will be evaluated.
- Lipids concentration [ Time Frame: 3 years ]Changes of lipids concentration in COCs users will be identified.
- Homeostasis model assessment [ Time Frame: 3 years ]Having the results of the glucose concentration in the blood and fasting insulin level tests, the homeostasis model assessment (HOMA) will be calculated and evaluated dynamic changes of this measurement, while using COCs.
- Free androgen Index [ Time Frame: 3 years ]Having the results of the T and SHBG in the blood Free Androgen Index (FAI) will be calculated. We will compare the effectiveness of diagnostic methods, such as serum free testosterone measured by ELISA-method and free androgen index for assessment of hyperandrogenism in young women with hirsutism.
- Sexual function and hormonal contraception [ Time Frame: 3 years ]The investigation should give answers to the questions of female sexual behavior, the quality of their sexual life and about the influence of COCs on the female mood and sexuality. The female sexual function and its disorders have not been investigated in Lithuania for young female group. The data of such investigation could become the basis for the sexual help centre and the diagnostics would improve.
- Androgen receptor polymorphism and hormonal contraception [ Time Frame: 3 years ]The relationship of androgen receptor - AR- repeat length in the AR gene will be evaluated.
- AR gene polymorphism and metabolic function. [ Time Frame: 3 yeras ]The correlation between AR gene polymorphism on metabolic function will be assessed.
- AR gene polymorphism and endocrine function [ Time Frame: 3 years ]The correlation between AR gene polymorphism on endocrine function will be assessed.
- AR gene polymorphism and blood coagulation parameters [ Time Frame: 3 years ]The correlation between AR gene polymorphism on blood coagulation parameters will be assessed.
- AR gene polymorphism and psychosexual function [ Time Frame: 3 years ]The correlation between AR gene polymorphism on psychosexual function will be assessed.
Biospecimen Retention: Samples With DNA
- Lipidogram, glycemia;
- Hormonal analyses by radioimmunoassay method ׃ total testosterone (T), free testosterone (FT), sex hormone binding globulin (SHBG), dehidroepiandrosterone sulphate (DHEAs), thyrotropin hormone (TSH), free thyroxine (FT4);
- Blood coagulation test׃ clotting time according to Ovren, fibrinogen, aPTT.
- Total blood picture test;
- Androgen receptor (AR) polymorphism test.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01852786
|Lithuanian University of Health Sciences|
|Kaunas, Lithuania, LT- 50009|
|Principal Investigator:||Birute Zilaitiene, Ass. Proff.||Lithuanian University of Health Sciences, Institute of Endocrinology|