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CompletedNCT01527526DMPAUpdated Jun 4, 2015

Depot-medroxyprogesterone Acetate (DMPA) Contraceptive Method and Metabolism

An observational study in Insulin Resistance, Cardiovascular Disease and Bone Loss, sponsored by University of Campinas, Brazil. Completed at 1 site in Brazil. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-04.

Sponsored by University of Campinas, Brazil · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
54
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Insulin Resistance
  • Cardiovascular Disease
  • Bone Loss
  • Eating Disorders
  • Thrombosis

Keywords

  • DMPA
  • insulin resistance
  • cardiovascular disease
  • BMI
  • weight gain
  • thrombosis
03

In context

Cardiovascular Diseases

4,905 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 54 is below the median of 563 across 1,486 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

University of Campinas, Brazil is the lead sponsor of 166 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
54 participants (actual)
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. insulin resistance

    insulin resistance diagnosed by hyperinsulinemic-euglycemic clamp at 0 and 12 months

    Time frame: 12 months

Secondary outcomes

  1. weight gain

    other arm of the study

    Time frame: 12 months

  2. eating disorder

    other arm of the study

    Time frame: 12 months

  3. loss of bone mass

    other arm of the study

    Time frame: 12 months

  4. changes in clotting factors

    other arm of the study

    Time frame: 12 months

07

Study locations

1 site
  • University of Campinas
    Campinas, São Paulo 13083-888, Brazil
08

References and documents

Publications

  • Modesto W, Bahamondes MV, Silva dos Santos P, Fernandes A, Dal'Ava N, Bahamondes L. Exploratory study of the effect of lifestyle counselling on bone mineral density and body composition in users of the contraceptive depot-medroxyprogesterone acetate. Eur J Contracept Reprod Health Care. 2014 Aug;19(4):244-9. doi: 10.3109/13625187.2014.924098. Epub 2014 Jun 13. PubMed 24923792 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01527526
Lead sponsor
University of Campinas, Brazil
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
Responsible party
Luis Bahamondes (MD Medical Doctor, University of Campinas, Brazil) — Principal investigator
First posted
Feb 7, 2012
Start date
Feb 2011
Primary completion
Feb 2013
Completion
Feb 2013
Last update
Jun 4, 2015

Study contacts

Luis Bahamondes, M.D.
principal investigator · University of Campinas, Brazil

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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