Contraceptive Affecting the Autonomic Nervous SystemPhase 3NCT01590849
Assessment of Autonomic Tone in Normotensive Women Using Combined Hormonal Oral Contraceptive Containing Drospirenone
A Phase 3 study testing Contraceptives, Oral, Combined (Yaz®) in people with Contraceptive Affecting the Autonomic Nervous System and Contraceptive Affecting Blood Pressure, run by Instituto do Coracao at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraceptive Affecting the Autonomic Nervous System, Contraceptive Affecting Blood Pressure
- What is being tested?
- Contraceptives, Oral, Combined (Yaz®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to May 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Contraceptive Affecting the Autonomic Nervous System, Contraceptive Affecting Blood Pressure
- Being tested
- Contraceptives, Oral, Combined (Yaz®)
- Keywords
- contraceptive agents, autonomic nervous system, blood pressure, risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contraceptives, Oral, Combined (Yaz®)Drug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| No hormonal contraception | No intervention | Not described |
| Hormonal Contraceptive | 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). Receives: Drug: Contraceptives, Oral, Combined (Yaz®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
combined hormonal oral contraceptive with drospirenone and its influence on the autonomic nervous system
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.
Measured: six months after the intervention
Secondary outcomes (1)
combined hormonal oral contraceptive with drospirenone and its influence on blood pressure
Measured: six month after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2012 (estimated)
- Study startJan 2011
- Primary completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Contraceptive Affecting the Autonomic Nervous SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto do Coracao
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marcelo Gil Nisenbaum, University of Sao Paulo General Hospital
- Investigators
- Marcelo G Nisenbaum, Principal investigator, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590849
- Sponsor's protocol ID
- nisenbaum1
- Status last verified
- May 2012
- First submitted
- 30 Apr 2012
- Last updated
- 3 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Carter JR, Klein JC, Schwartz CE. Effects of oral contraceptives on sympathetic nerve activity during orthostatic stress in young, healthy women. Am J Physiol Regul Integr Comp Physiol. 2010 Jan;298(1):R9-R14. doi: 10.1152/ajpregu.00554.2009. Epub 2009 Oct 14.
PubMed 19828840Minson CT, Halliwill JR, Young TM, Joyner MJ. Sympathetic activity and baroreflex sensitivity in young women taking oral contraceptives. Circulation. 2000 Sep 26;102(13):1473-6. doi: 10.1161/01.cir.102.13.1473.
PubMed 11004135
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Autonomic Tone in Normotensive Women Using Combined Hormonal Oral Contraceptive Containing Drospirenone
- ClinicalTrials.gov ID
- NCT01590849
- Acronym / sponsor ID
- nisenbaum1
- Conditions
- Contraceptive Affecting the Autonomic Nervous System, Contraceptive Affecting Blood Pressure
- Keywords
- contraceptive agents, autonomic nervous system, blood pressure, risk
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Instituto do CoracaoOther government
- Study start
- Jan 2011
- Primary completion
- May 2012 (estimated)
- First posted
- 3 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No hormonal contraception | No intervention | – |
| Hormonal Contraceptive | Active comparator | Drug: Contraceptives, Oral, Combined (Yaz®)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). |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- positive pregnancy test
- category 3 or 4 classification on WHO's Medical Eligibility Criteria for Contraceptive
- smoking
- obesity
- fasting glucose above 100 mg/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contraceptives, Oral, Combined (Yaz®)Also: 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. | Drug | Hormonal Contraceptive |
Primary outcome
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.
1 secondary outcome
combined hormonal oral contraceptive with drospirenone and its influence on blood pressure
Time frame: six month after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2012.
- Background: PubMed 19828840Carter JR, Klein JC, Schwartz CE. Effects of oral contraceptives on sympathetic nerve activity during orthostatic stress in young, healthy women. Am J Physiol Regul Integr Comp Physiol. 2010 Jan;298(1):R9-R14. doi: 10.1152/ajpregu.00554.2009. Epub 2009 Oct 14.
- Background: PubMed 11004135Minson CT, Halliwill JR, Young TM, Joyner MJ. Sympathetic activity and baroreflex sensitivity in young women taking oral contraceptives. Circulation. 2000 Sep 26;102(13):1473-6. doi: 10.1161/01.cir.102.13.1473.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcelo G Nisenbaum principal investigator
University of Sao Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Contraceptives, Oral, Combined (Yaz®) in people with Contraceptive Affecting the Autonomic Nervous System and Contraceptive Affecting Blood Pressure, run by Instituto do Coracao at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
combined hormonal oral contraceptive with drospirenone and its influence on the autonomic nervous system (time frame: six months after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01590849, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2012.