Depot-medroxyprogesterone Acetate (DMPA) Contraceptive Method and Metabolism (DMPA)

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. Identifier: NCT01527526
Recruitment Status : Completed
First Posted : February 7, 2012
Last Update Posted : June 4, 2015
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Luis Bahamondes, University of Campinas, Brazil

Brief Summary:


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


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 or disease
Insulin Resistance Cardiovascular Disease Bone Loss Eating Disorders Thrombosis

Study Type : Observational
Actual Enrollment : 54 participants
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
Study Start Date : February 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. insulin resistance [ Time Frame: 12 months ]
    insulin resistance diagnosed by hyperinsulinemic-euglycemic clamp at 0 and 12 months

Secondary Outcome Measures :
  1. weight gain [ Time Frame: 12 months ]
    other arm of the study

  2. eating disorder [ Time Frame: 12 months ]
    other arm of the study

  3. loss of bone mass [ Time Frame: 12 months ]
    other arm of the study

  4. changes in clotting factors [ Time Frame: 12 months ]
    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.

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.

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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.

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

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 identifier (NCT number): NCT01527526

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
Principal Investigator: Luis Bahamondes, M.D. University of Campinas, Brazil

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Luis Bahamondes, MD Medical Doctor, University of Campinas, Brazil Identifier: NCT01527526     History of Changes
Other Study ID Numbers: 09/2011/PC
First Posted: February 7, 2012    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: June 2015

Keywords provided by Luis Bahamondes, University of Campinas, Brazil:
insulin resistance
cardiovascular disease
weight gain

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