Blood PressurePhase 4NCT02342093
Contraceptives Containing Drospirenone and Blood Pressure
A Phase 4 study testing 30EE+DRSP and 20EE+DRSP in people with Blood Pressure and Contraception, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Background: Drospirenone (DRSP) seems to have a favorable effect on blood pressure (BP); however, when associated with ethinylestradiol (EE), this effect does not seem to occur. This study has the objective to assess possible differences in BP associated with the use of COCs containing DRSP with different doses of… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Contraception
- What is being tested?
- 30EE+DRSP and 20EE+DRSP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Sep 2014
- Phase
- Phase 4
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- sexually active women who did not wish to become pregnant,
- aged between 18 and 35,
- with menstrual cycles lasting between 24 and 32 days,
- body mass index (BMI) between 18.0 and 29.9 kg/m2
Who cannot join
- smoking,
- use of drugs and/or alcohol,
- clinical and/or laboratory signs of hyperandrogenism,
- use of hormonal contraception within six months before the initiation of the study,
- presence of chronic and/or acute inflammatory processes,
- use of medications with endothelial effects (e.g., statins),
- breastfeeding or having stopped breastfeeding within two months before the initiation of the study,
- medical conditions classified as category 3 or 4 according to the WHO medical eligibility criteria for contraceptive prescription
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Two Contraceptives Containing Drospirenone on Blood Pressure in Normotensive Women: a Randomized Controlled Trial
Background: Drospirenone (DRSP) seems to have a favorable effect on blood pressure (BP); however, when associated with ethinylestradiol (EE), this effect does not seem to occur. This study has the objective to assess possible differences in BP associated with the use of COCs containing DRSP with different doses of ethinylestradiol.
Materials and methods: This open-label parallel-group randomized clinical trial involved women randomized to use either 30 mcg of EE+DRSP (n=22) or 20 mcg of EE+DRSP (n=22). Daytime, nighttime and 24-hour BP were evaluated by ambulatory blood pressure monitoring (ABPM) at the beginning of the trial and six months after drug therapy.
- Conditions
- Blood Pressure, Contraception
- Being tested
- 30EE+DRSP, 20EE+DRSP
- Keywords
- Ambulatory Blood Pressure Monitoring, Drospirenone, Oral contraceptive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30EE+DRSPDrug
Combined oral contraceptive containing 30 mcg of ethinylestradiol + 3 mg of drospirenone (30EE+DRSP), 1 pill once a day with a pause of seven days between the blisters for 6 months
20EE+DRSPDrug
Combined oral contraceptive containing 30 mcg of ethinylestradiol + 3 mg of drospirenone (20EE+DRSP), 1 pill once a day with a pause of four days between the blisters for 6 months
| Study group | Role | What they receive |
|---|---|---|
| 30EE+DRSP | Active comparator | Combined oral contraceptive containing 30 mcg of ethinylestradiol + 3 mg of drospirenone (30EE+DRSP), 1 pill once a day with a pause of seven days between the blisters for 6 months Receives: Drug: 30EE+DRSP |
| 20EE+DRSP | Active comparator | Combined oral contraceptive containing 20 mcg of ethinylestradiol + 3 mg of drospirenone (20EE+DRSP), 1 pill once a day with a pause of four days between the blisters for 6 months Receives: Drug: 20EE+DRSP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Twenty-four-hour mean systolic blood pressure (SBP), 24-hour mean diastolic blood pressure (DBP), and day and nighttime SBP and DBP were measured by ambulatory blood pressure monitoring
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startJan 2011
- Primary completionJul 2013
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Carolina Sales Vieira, University of Sao Paulo
- Investigators
- Carolina S Vieira, MD, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342093
- Sponsor's protocol ID
- USP-DRSP
- Status last verified
- Jan 2015
- First submitted
- 14 Jan 2015
- Last updated
- 19 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Two Contraceptives Containing Drospirenone on Blood Pressure in Normotensive Women: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02342093
- Acronym / sponsor ID
- USP-DRSP
- Conditions
- Blood Pressure, Contraception
- Keywords
- Ambulatory Blood Pressure Monitoring, Drospirenone, Oral contraceptive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Jan 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 19 Jan 2015 (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.
Background: Drospirenone (DRSP) seems to have a favorable effect on blood pressure (BP); however, when associated with ethinylestradiol (EE), this effect does not seem to occur. This study has the objective to assess possible differences in BP associated with the use of COCs containing DRSP with different doses of ethinylestradiol.
Materials and methods: This open-label parallel-group randomized clinical trial involved women randomized to use either 30 mcg of EE+DRSP (n=22) or 20 mcg of EE+DRSP (n=22). Daytime, nighttime and 24-hour BP were evaluated by ambulatory blood pressure monitoring (ABPM) at the beginning of the trial and six months after drug therapy.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30EE+DRSP | Active comparator | Drug: 30EE+DRSPCombined oral contraceptive containing 30 mcg of ethinylestradiol + 3 mg of drospirenone (30EE+DRSP), 1 pill once a day with a pause of seven days between the blisters for 6 months |
| 20EE+DRSP | Active comparator | Drug: 20EE+DRSPCombined oral contraceptive containing 20 mcg of ethinylestradiol + 3 mg of drospirenone (20EE+DRSP), 1 pill once a day with a pause of four days between the blisters for 6 months |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- sexually active women who did not wish to become pregnant,
- aged between 18 and 35,
- with menstrual cycles lasting between 24 and 32 days,
- body mass index (BMI) between 18.0 and 29.9 kg/m2
Key exclusion criteria (8 listed)
- smoking,
- use of drugs and/or alcohol,
- clinical and/or laboratory signs of hyperandrogenism,
- use of hormonal contraception within six months before the initiation of the study,
- presence of chronic and/or acute inflammatory processes,
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 |
|---|---|---|
| 30EE+DRSPCombined oral contraceptive containing 30 mcg of ethinylestradiol + 3 mg of drospirenone (30EE+DRSP), 1 pill once a day with a pause of seven days between the blisters for 6 months | Drug | 30EE+DRSP |
| 20EE+DRSPCombined oral contraceptive containing 30 mcg of ethinylestradiol + 3 mg of drospirenone (20EE+DRSP), 1 pill once a day with a pause of four days between the blisters for 6 months | Drug | 20EE+DRSP |
Primary outcome
Blood pressure
Time frame: 24 hours
Twenty-four-hour mean systolic blood pressure (SBP), 24-hour mean diastolic blood pressure (DBP), and day and nighttime SBP and DBP were measured by ambulatory blood pressure monitoring
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2015.
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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.
Carolina S Vieira, MD, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 30EE+DRSP and 20EE+DRSP in people with Blood Pressure and Contraception, run by University of Sao Paulo 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 8 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: finished, as of the sponsor's last update on 19 Jan 2015. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blood pressure (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2015.