Acceptability and Continuation Rate of Implanon in a Brazilian Public Sector

Contraceptive Usage Clinical Trial

Official title:

Acceptability and Continuation Rate of Implanon in a Brazilian Public Sector

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01392157
• Other study ID #: 07/2011/PC
• Status: Completed
• Phase: Phase 4
• First received: June 16, 2011
• Last updated: November 26, 2013
• Start date: June 2011
• Est. completion date: July 2013

Study information

• Verified date: November 2013
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The main side-effect of Implanon is the changes induces in bleeding patterns including amenorrhea, infrequent to irregular bleeding and frequent and prolonged bleeding; without any previous symptom and it was characterized as "breakthrough bleeding" (BTB). BTB is the main causes of early discontinuations. Unfortunately, there is no indication to predict prior to insertion what sort of bleeding pattern any individual woman may have after insertion and the proposed treatments were disappointed. Nevertheless, previous studies with other progestin-only contraceptives (including Implanon) provide evidence that the provision of adequate and intensive counseling to potential users and new acceptors about bleeding changes can help to improve method continuation.

The availability of Implanon in the public sector could help in the development of strategies to introduce the method in the public sector network and the training of medical residents.

Description:

100 women were either allocated to received Implanon contraceptive implant, the LNG-IUS or TCu380A copper-IUD. The women were allocated according to their preference on each of the contraceptive methods.

half of the women will receive the common counseling at the clinic and the other 50% will receive intense counselling about menstrual changes induced by these three contraceptive methods. The continuation rate up to one year will be evaluated through life-table analysis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Women 18 to 40 years

• New users of Implanon, IUDs and the LNG-IUS TCu380A

Exclusion Criteria:

• Contraindications to contraceptive methods

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bleeding Due to Intrauterine Contraceptive Device
• Contraceptive Usage

Intervention

Device:
• copper-releasing intrauterine device
100 women received a 380 mm2 of copper releasing intrauterine device
• ENG-releasing implant
60 mcg/day releasing etonogestrel implant
• LNG-releasing intrauterine system
a LNG-IUS releasing 20 mcd/day of LNG
• LNG-IUS
100 women will receive an LNG-IUS

Locations

Country	Name	City	State
Brazil	University of Campinas	Campinas	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of acceptability of Implanon in comparison to the TCu380A IUD and the LNG-IUS	All the acceptors (contraceptive implants, the LNG-IUS and the copper IUD) will be follow for up to one year and we will record all the adverse events and mainly all the discontinuations due to bleeding irregularities, to compare one group to other and the half of the women who will receive intense counseling in comparison to the women with regular counseling at the clinic.	Participants will receive counseling before admission and at 12 months after	No