Contraceptives Containing Drospirenone and Blood Pressure

Blood Pressure Clinical Trial

Official title:

Effects of Two Contraceptives Containing Drospirenone on Blood Pressure in Normotensive Women: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02342093
• Other study ID #: USP-DRSP
• Status: Completed
• Phase: Phase 4
• First received: January 14, 2015
• Last updated: January 14, 2015
• Start date: January 2011
• Est. completion date: September 2014

Study information

• Verified date: January 2015
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: September 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Blood Pressure
• Contraception

Intervention

Drug:
• 30EE+DRSP
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+DRSP
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

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	Ribeirão Preto	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 hours	Yes