Assessment of Autonomic Tone in Normotensive Women Using Combined Hormonal Oral Contraceptive Containing Drospirenone
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ClinicalTrials.gov Identifier: NCT01590849 |
Recruitment Status : Unknown
Verified May 2012 by Marcelo Gil Nisenbaum, University of Sao Paulo General Hospital.
Recruitment status was: Active, not recruiting
First Posted : May 3, 2012
Last Update Posted : May 3, 2012
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Condition or disease | Intervention/treatment | Phase |
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Contraceptive Affecting the Autonomic Nervous System Contraceptive Affecting Blood Pressure | Drug: Contraceptives, Oral, Combined (Yaz®) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 69 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Official Title: | Assessment of Autonomic Tone in Normotensive Women Using Combined Hormonal Oral Contraceptive Containing Drospirenone |
Study Start Date : | January 2011 |
Estimated Primary Completion Date : | May 2012 |

Arm | Intervention/treatment |
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No Intervention: No hormonal contraception | |
Active Comparator: Hormonal Contraceptive
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).
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Drug: Contraceptives, Oral, Combined (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:
Subjects were tested once before the introduction of the contraceptive method and again after 6 months of its use. Other Name: Brand Name in Brazil - (Yaz®) |
- combined hormonal oral contraceptive with drospirenone and its influence on the autonomic nervous system [ Time Frame: six months after the intervention ]
The participants in this study will be 80 healthy women. 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 EE and 3 mg DRSP (Yaz®)(n=40).
- Control group: healthy women, users of nonhormonal methods of contraception (condoms or copper IUD) (n=40).
The acquisition of autonomic parameters will be performed through the device Finometer.
- combined hormonal oral contraceptive with drospirenone and its influence on blood pressure [ Time Frame: six month after the intervention ]

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Ages Eligible for Study: | 20 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

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): NCT01590849
Brazil | |
Marcelo Gil Nisenbaum | |
Sao Paulo, São Paulo, Brazil, 05403-000 |
Principal Investigator: | Marcelo G Nisenbaum | University of Sao Paulo General Hospital |
Responsible Party: | Marcelo Gil Nisenbaum, post graduate and contributor to the medical clinic for family planning of the Department of Gynecology of Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, University of Sao Paulo General Hospital |
ClinicalTrials.gov Identifier: | NCT01590849 |
Other Study ID Numbers: |
nisenbaum1 |
First Posted: | May 3, 2012 Key Record Dates |
Last Update Posted: | May 3, 2012 |
Last Verified: | May 2012 |
contraceptive agents autonomic nervous system blood pressure risk |
Contraceptive Agents Contraceptives, Oral Contraceptives, Oral, Combined |
Reproductive Control Agents Physiological Effects of Drugs Contraceptive Agents, Female |