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Depot-medroxyprogesterone Acetate (DMPA) Contraceptive Method and Metabolism

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University of Campinas, Brazil.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Luis Bahamondes, University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01527526
First received: November 16, 2011
Last updated: June 17, 2013
Last verified: February 2012
  Purpose

Objective:

The purpose of this study is to determine the etiology of the weight increase in Depot-medroxyprogesterone Acetate (DMPA) users.

Method:

Prospective study with 100 women, aged 18-40 years old and BMI < 30kg/m², paired with users of a non hormonal method follow for two years. Will be included only women who never used DMPA. There will be evaluated habit, blood pressure, anthropometric measure, distribution of corporal fat, lipids profile and glycemia parameters every six months. Thirty women and their control group will performed a euglycemic-hyperinsulinemic clamp to evaluate the resistance of insulin, adiponectin,neuropeptide Y, apolipoprotein A/B and arterial evaluation with ultrasound, intimal and media measure. Anova analysis for repeated samples. The metabolic alterations should elucidate the etiology, and the beginning of the sub clinical cardiovascular disease should be shown/discarded with the arterial evaluation.


Condition
Insulin Resistance
Cardiovascular Disease
Bone Loss
Eating Disorders
Thrombosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prospective Study for Evaluation of the Insulin Resistance, Lipid Metabolism and Sub Clinical Cardiovascular Disease in Women Who Initiate the Depot-medroxyprogesterone Acetate (DMPA) Contraceptive Method With in Follow-up for Two Years

Resource links provided by NLM:


Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:
  • insulin resistance [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    insulin resistance diagnosed by hyperinsulinemic-euglycemic clamp at 0 and 12 months


Secondary Outcome Measures:
  • weight gain [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    other arm of the study

  • eating disorder [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    other arm of the study

  • loss of bone mass [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    other arm of the study

  • changes in clotting factors [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    other arm of the study


Biospecimen Retention:   Samples Without DNA

Serum samples for determination of lipid profile, insulin, glucose, coagulation factors, neuropeptide Y and factors related to bone mineral density.


Estimated Enrollment: 100
Study Start Date: February 2011
Estimated Study Completion Date: May 2014
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Will be included women new-users DMPA, looking for the clinic's family planning FCM-UNICAMP, from primary care centers in Campinas, São Paulo, Brazil.

Criteria

Inclusion Criteria:

  • 18-40 years
  • new users of DMPA
  • BMI<30kg/m²

Exclusion Criteria:

  • diabetes mellitus and 2 present or fasting glucose> 100mg/dl and / or blood glucose> 140mg/dl after ingestion of 75mg of oral glucose
  • first-degree relatives with diabetes mellitus
  • period of lactation
  • hypertension, with or without treatment
  • hyper and hypothyroidism
  • chronic renal failure
  • transplant of any organ
  • women using drugs that may be related to weight gain and / or development of insulin resistance and chronic use of corticosteroids, antipsychotics, statins, and thiazide,
  • hirsutism and/or hyperandrogenism
  • polycystic Ovary Syndrome (PCOS)
  • women with acanthosis nigricans
  • women who have used depoprovera at some point in their reproductive lives,
  • women who have performed bariatric surgery
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01527526

Locations
Brazil
University of Campinas
Campinas, São Paulo, Brazil, 13083-888
Sponsors and Collaborators
University of Campinas, Brazil
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Luis Bahamondes, M.D. University of Campinas, Brazil
  More Information

No publications provided

Responsible Party: Luis Bahamondes, MD Medical Doctor, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT01527526     History of Changes
Other Study ID Numbers: 09/2011/PC
Study First Received: November 16, 2011
Last Updated: June 17, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Campinas, Brazil:
DMPA
insulin resistance
cardiovascular disease
BMI
weight gain
thrombosis

Additional relevant MeSH terms:
Cardiovascular Diseases
Eating Disorders
Insulin Resistance
Thrombosis
Embolism and Thrombosis
Glucose Metabolism Disorders
Hyperinsulinism
Mental Disorders
Metabolic Diseases
Vascular Diseases
Contraceptive Agents
Medroxyprogesterone
Medroxyprogesterone Acetate
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Contraceptive Agents, Female
Contraceptive Agents, Male
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014