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Completed

NCT Number: NCT02342093

Contraceptives Containing Drospirenone and Blood Pressure

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.

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Key information

Conditions

Blood Pressure Contraception

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Sao Paulo

Ribeirão Preto, São Paulo, 14049-900, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Jan 19, 2015
Registry last updated
Jan 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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