Safety of the Etonogestrel-releasing Implant During the Puerperium of Healthy Women

NCT00828542 | Completed Results

• 1 other identifier: HCRP4432/2007
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study to assess the safety of the etonogestrel-releasing subdermal implant (Implanon) inserted during the immediate puerperium of healthy women.

Conditions

Breastfeeding; Contraception

Keywords

Adverse Effects; Etonogestrel; Postpartum period; Contraception; Hemostasis; Metabolism

Outcome Measures

Primary Outcomes (1)

• Etonogestrel-releasing Contraceptive Subdermal Implant Inserted During the Immediate Puerperium Effects on the Hemostatic System of Healthy Women Over a Period of Twelve Weeks

  Activated protein C (APC) resistance is the most important marker of coagulation system in women using hormonal contraceptive methods. APC resistance was determined by testing the effect of APC on the endogenous thrombin potential (ETP) using the Calibrated Automated Thrombogram® (CAT) assay. The sensitivity ratio or APC (APCsr) of each plasma sample was determined in the presence or absence of approximately 4 nM APC (Enzyme Research Laboratories, Swansea, United Kingdom). The APC concentration was adjusted to maintain the residual thrombin generation activity in normal pooled plasma at approximately 10%. Normal pooled plasma was run in parallel on each plate. The normalized ratio (nAPCsr) was determined by dividing the APCsr of an individual sample by the APCsr of the pooled plasma. Thus, nAPCsr \>1.0 indicated APC resistance.

  12 weeks

Secondary Outcomes (1)

• Maternal (Clinical and Metabolic) and Neonatal (Clinical) Safety Regarding the Use of the Etonogestrel Implant During the Immediate Postpartum Period and the First 12 Weeks Postpartum

  12 weeks

Study Arms (2)

etonogestrel implant

EXPERIMENTAL

Etonogestrel releasing contraceptive implant (Implanon®, NV Organon, Oss, The Netherlands) inserted 24-48 h after delivery. It is compounded by 68mg of etonogestrel, 3years of duration.

Drug: etonogestrel implant

depot medroxyprogesterone acetate

ACTIVE COMPARATOR

At the 6th week postpartum, this group received intramuscular 150 mg of depot medroxyprogesterone acetate (Contracept®, EMS Sigma Pharma, Hortolandia, Brazil).

Drug: depot medroxyprogesterone acetate

Interventions

etonogestrel implant DRUG

Etonogestrel-releasing subdermal implant (Implanon) inserted during the immediate postpartum period (from 24 to 48 hours postpartum)

Also known as: Implanon, Etonogestrel implant

etonogestrel implant

depot medroxyprogesterone acetate DRUG

150 mg medroxyprogesterone administered I.M. every three months starting 6 weeks after delivery

Also known as: medroxyprogesterone

depot medroxyprogesterone acetate

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age between 18 and 35 years
• Postpartum contraception desire

You may not qualify if:

• smoking, alcoholism or drug addiction
• presence of systemic diseases (diabetis melittus, cardiovascular disease, autoimmune diseases, liver disease, thyroid disease, or congenital renal hyperplasia)
• having a body mass index ≥ 30 kg/m2
• personal history of arterial or venous thrombosis
• using any medication that might interfere with blood coagulation or with the assessment of haemostatic and inflammatory variables
• presenting alterations in hepatic enzymes
• being allergic to local anaesthetics (xylocaine)

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University of Sao Paulo

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Related Publications (2)

• Brito MB, Ferriani RA, Quintana SM, Yazlle ME, Silva de Sa MF, Vieira CS. Safety of the etonogestrel-releasing implant during the immediate postpartum period: a pilot study. Contraception. 2009 Dec;80(6):519-26. doi: 10.1016/j.contraception.2009.05.124. Epub 2009 Jul 10.

  PMID: 19913145 RESULT

• Brito MB, Ferriani RA, Meijers JC, Garcia AA, Quintana SM, Silva de Sa MF, Vieira CS. Effects of the etonogestrel-releasing contraceptive implant inserted immediately postpartum on maternal hemostasis: a randomized controlled trial. Thromb Res. 2012 Sep;130(3):355-60. doi: 10.1016/j.thromres.2012.03.029. Epub 2012 Apr 28.

  PMID: 22542366 RESULT

MeSH Terms

Conditions

Breast Feeding

Interventions

etonogestrel; Medroxyprogesterone

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

Patients were not blinded to treatment. However, this was not possible because the ENG group received a subdermal contraceptive implant, whereas, for ethical reasons, the control group could not receive a placebo implant.

Results Point of Contact

• Title: Dr. Milena Bastos Brito
• Organization: Sao Paulo University

milenabastos@usp.br

551636022814

Study Officials

• Carolina S Vieira, MD, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Milena B Brito, MD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 23, 2009
• First Posted: January 26, 2009
• Study Start: July 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: May 15, 2017
• Results First Posted: May 15, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)