This trial is active, not recruiting.

Conditions contraceptive affecting the autonomic nervous system, contraceptive affecting blood pressure
Treatment contraceptives, oral, combined (yaz®)
Phase phase 3
Sponsor Instituto do Coracao
Start date January 2011
End date May 2012
Trial size 69 participants
Trial identifier NCT01590849, nisenbaum1


The use of combined oral contraceptives has been associated with increased risk of adverse cardiovascular events. The exact mechanism by which these drugs exert this influence is uncertain. It is possible that changes in autonomic nervous system are involved. The objective of these study was to evaluate the effect of the use of a contraceptive containing 20 mcg of ethinyl estradiol and 3mg of drospirenone in the autonomic nervous system in healthy women. Few studies have been conducted in the field of hormonal contraception and evaluation of the autonomic nervous system work and no prospective, controlled study was published so far. These study will be the first.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
(No Intervention)
(Active Comparator)
healthy women, users of COC containing 20 mcg EE and 3 mg DRSP (Yaz®), 24 days of active pills, 4 days of pill-free interval (n=40).
contraceptives, oral, combined (yaz®) Brand Name in Brazil - (Yaz®)
After a counseling session concerning the advantages, disadvantages and side effects of contraceptive methods (COC or nonhormonal methods), the volunteers were divided into two study groups according to the method they chose to use as follows: Case group: healthy women, users of COC containing 20 mcg ethynil estradiol and 3 mg drospirenone , 24 days of active pills, 4 days of pill-free interval (n=40). Control group: healthy women, users of nonhormonal methods of contraception (condoms or copper IUD) (n=40). Subjects were tested once before the introduction of the contraceptive method and again after 6 months of its use.

Primary Outcomes

combined hormonal oral contraceptive with drospirenone and its influence on the autonomic nervous system
time frame: six months after the intervention

Secondary Outcomes

combined hormonal oral contraceptive with drospirenone and its influence on blood pressure
time frame: six month after the intervention

Eligibility Criteria

Female participants from 20 years up to 40 years old.

Inclusion Criteria: - 20 to 40 years old - no use of hormonal contraceptives for at least 6 months before the study - need for contraceptive method - willingness to participate in the study Exclusion Criteria: - positive pregnancy test - category 3 or 4 classification on WHO's Medical Eligibility Criteria for Contraceptive - smoking - obesity - fasting glucose above 100 mg/dL - abnormalities in lipid profile - use of other medications

Additional Information

Official title Assessment of Autonomic Tone in Normotensive Women Using Combined Hormonal Oral Contraceptive Containing Drospirenone
Principal investigator Marcelo G Nisenbaum
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by Instituto do Coracao.