Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 28 of 101 for:    DROSPIRENONE AND ETHINYL ESTRADIOL AND ethinylestradiol

Contraceptives Containing Drospirenone and Blood Pressure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02342093
Recruitment Status : Completed
First Posted : January 19, 2015
Last Update Posted : January 19, 2015
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Carolina Sales Vieira, University of Sao Paulo

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.


Condition or disease Intervention/treatment Phase
Blood Pressure Contraception Drug: 30EE+DRSP Drug: 20EE+DRSP Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: Effects of Two Contraceptives Containing Drospirenone on Blood Pressure in Normotensive Women: a Randomized Controlled Trial
Study Start Date : January 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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
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

Active Comparator: 20EE+DRSP
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
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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02342093


Locations
Layout table for location information
Brazil
University of Sao Paulo
Ribeirão Preto, SP, Brazil, 14049-900
Sponsors and Collaborators
University of Sao Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Layout table for investigator information
Principal Investigator: Carolina S Vieira, MD, PhD University of Sao Paulo

Layout table for additonal information
Responsible Party: Carolina Sales Vieira, Professor of Obstetrics and Gynecology, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02342093     History of Changes
Other Study ID Numbers: USP-DRSP
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: January 19, 2015
Last Verified: January 2015
Keywords provided by Carolina Sales Vieira, University of Sao Paulo:
Ambulatory Blood Pressure Monitoring
Drospirenone
Oral contraceptive
Additional relevant MeSH terms:
Layout table for MeSH terms
Drospirenone
Ethinyl Estradiol
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents