The Effect of Hormonal Contraception on Female
HORMCONTRA
Metabolic, Androgen, Blood Coagulation Parameters and Female Sexual Function in Relation to Oral Contraceptive Use and Androgen Receptor Polymorphisms in Healthy Lithuanian Women
2 other identifiers
observational
340
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 29, 2013
CompletedFirst Posted
Study publicly available on registry
May 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedMay 14, 2013
May 1, 2013
2 years
April 29, 2013
May 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hirsutism
The expression of terminal hair growth using Ferriman- Gallwey scoring system in Lithuanian women will be assessed.
2 years
Secondary Outcomes (4)
Blood coagulation parameters and hormonal contraception
3 years
Lipids concentration
3 years
Homeostasis model assessment
3 years
Free androgen Index
3 years
Other Outcomes (6)
Sexual function and hormonal contraception
3 years
Androgen receptor polymorphism and hormonal contraception
3 years
AR gene polymorphism and metabolic function.
3 yeras
- +3 more other outcomes
Study Arms (2)
Contraceptives, Oral, Combined
The women, presenting for hormonal contraception use and with no contraindications for hormonal therapy.
Controls
The women, presenting for non- hormonal contraception- barrier contraception methods -BCM- or natural family planning methods- NFPM.
Interventions
• 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).
The women, The women presenting for non-hormonal contraception use, will be recommended BCM or NFPM.
Eligibility Criteria
340 healthy Lithuanian women age 18- 40 years with regular menstruale cycle (22- 35 days) presenting for routine gynecologic concern or contraception purposes.
You may qualify if:
- years old women applying to obstetrician-gynaecologist for contraception use or for preventive health care and giving their consent to participate in the study (who signed The Informed Consent Form) will be eligible to participate in the study. It is important to note that these women should not have underlying medical conditions (chronic non - infection diseases, chronic or acute infection diseases).
- Not using hormonal contraception for 6 months or more.
You may not qualify if:
- Women applying for obstetrician-gynaecologist consultation on gynaecological pathology.
- Women with underlying medical conditions (chronic non - infection diseases, chronic or acute infection diseases).
- Women, planning to get pregnant during the 12 months.
- Pregnant women (suspected or confirmed pregnancy).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lithuanian University of Health Sciences
Kaunas, LT- 50009, Lithuania
Biospecimen
1. Lipidogram, glycemia; 2. 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); 3. Blood coagulation test׃ clotting time according to Ovren, fibrinogen, aPTT. 4. Total blood picture test; 5. Androgen receptor (AR) polymorphism test.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Birute Zilaitiene, Ass. Proff.
Lithuanian University of Health Sciences, Institute of Endocrinology
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD student
Study Record Dates
First Submitted
April 29, 2013
First Posted
May 14, 2013
Study Start
February 1, 2013
Primary Completion
February 1, 2015
Study Completion
February 1, 2016
Last Updated
May 14, 2013
Record last verified: 2013-05