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The Effect of Hormonal Contraception on Female (HORMCONTRA)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2013 by Lina Ciaplinskiene, Lithuanian University of Health Sciences.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01852786
First Posted: May 14, 2013
Last Update Posted: May 14, 2013
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.
Information provided by (Responsible Party):
Lina Ciaplinskiene, Lithuanian University of Health Sciences
  Purpose

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 Intervention
Adverse Effect of Oral Contraceptives, Initial Encounter Other: Contraceptives, Oral, Combined Other: Controls

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Lina Ciaplinskiene, Lithuanian University of Health Sciences:

Primary Outcome Measures:
  • Hirsutism [ Time Frame: 2 years ]
    The expression of terminal hair growth using Ferriman- Gallwey scoring system in Lithuanian women will be assessed.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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
  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.

Estimated Enrollment: 340
Study Start Date: February 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Controls
The women, presenting for non- hormonal contraception- barrier contraception methods -BCM- or natural family planning methods- NFPM.
Other: Controls
The women, The women presenting for non-hormonal contraception use, will be recommended BCM or NFPM.
Other Name: NATURAL FAMILY PLANNING

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
340 healthy Lithuanian women age 18- 40 years with regular menstruale cycle (22- 35 days) presenting for routine gynecologic concern or contraception purposes.
Criteria

Inclusion Criteria:

  1. 18 - 40 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).
  2. Not using hormonal contraception for 6 months or more.

Exclusion Criteria:

  1. Women applying for obstetrician-gynaecologist consultation on gynaecological pathology.
  2. Women with underlying medical conditions (chronic non - infection diseases, chronic or acute infection diseases).
  3. Women, planning to get pregnant during the 12 months.
  4. Pregnant women (suspected or confirmed pregnancy).
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01852786


Locations
Lithuania
Lithuanian University of Health Sciences
Kaunas, Lithuania, LT- 50009
Sponsors and Collaborators
Lithuanian University of Health Sciences
Investigators
Principal Investigator: Birute Zilaitiene, Ass. Proff. Lithuanian University of Health Sciences, Institute of Endocrinology
  More Information

Responsible Party: Lina Ciaplinskiene, PhD student, Lithuanian University of Health Sciences
ClinicalTrials.gov Identifier: NCT01852786     History of Changes
Other Study ID Numbers: Contraception
contraception2013 ( Registry Identifier: Lina Ciaplinskiene )
First Submitted: April 29, 2013
First Posted: May 14, 2013
Last Update Posted: May 14, 2013
Last Verified: May 2013

Keywords provided by Lina Ciaplinskiene, Lithuanian University of Health Sciences:
Contraception
Hyperandrogenism
Female sexual function

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female