A Bioequivalence Study of IMPLANON and Radiopaque IMPLANON (34528)(P05720)
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|ClinicalTrials.gov Identifier: NCT00620464|
Recruitment Status : Completed
First Posted : February 21, 2008
Results First Posted : May 17, 2010
Last Update Posted : August 13, 2015
|Condition or disease||Intervention/treatment||Phase|
|Contraception||Drug: Radiopaque Implanon Drug: Implanon (etonogestrel implant)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Parallel Group, Bioequivalence Study of IMPLANON and Radiopaque IMPLANON|
|Study Start Date :||May 2005|
|Primary Completion Date :||February 2009|
|Study Completion Date :||February 2009|
Active Comparator: Radiopaque Implanon (ro imp)
The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate.
Drug: Radiopaque Implanon
Radiopaque rod for 3 years
Active Comparator: Implanon (imp)
Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and
2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane.
The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after
insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year.
Drug: Implanon (etonogestrel implant)
Implanon (etonogestrel implant) for 3 years
- Bioequivalence of Implanon® and Radiopaque Implanon. [ Time Frame: 3 years ]
Bioequivalence testing was performed based on serum etonogestrel AUC0-6months, AUC0-24months, and AUC0-36months. Bioequivalence was to be concluded when the 90% confidence limits of AUC0-6months, AUC0-24months, and AUC0-36months were fully contained within the acceptance range of 0.80-1.25.
AUC0-6months (Area under the curve from zero to six months).
AUC0-24months (Area under the curve from zero to 24 months).
AUC0-36months (Area under the curve from zero to 36 months).
- Bioequivalence of Implanon® and Radiopaque Implanon [ Time Frame: 3 years ]
Bioequivalence testing was performed based on serum etonogestrel Cmax. Bioequivalence was to be concluded when the 90% confidence limits of Cmax were fully contained within the acceptance range of 0.80-1.25.
Cmax (pg/mL): Peak concentration.