Contraceptives Containing Drospirenone and Blood Pressure

NCT02342093 | Completed Phase 4

• 1 other identifier: USP-DRSP
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Blood Pressure; Contraception

Keywords

Ambulatory Blood Pressure Monitoring; Drospirenone; Oral contraceptive

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Drug: 20EE+DRSP

Interventions

30EE+DRSP DRUG

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

30EE+DRSP

20EE+DRSP DRUG

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

20EE+DRSP

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

University of Sao Paulo

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Study Officials

• Carolina S Vieira, MD, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: January 14, 2015
• First Posted: January 19, 2015
• Study Start: January 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: September 1, 2014
• Last Updated: January 19, 2015

Record last verified: 2015-01

Locations

BR (1)