A Bioequivalence Study of IMPLANON and Radiopaque IMPLANON (34528)(COMPLETED)(P05720) - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Bio-equivalence Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Condition:	Contraception
Interventions:	Drug: Radiopaque Implanon Drug: Implanon (etonogestrel implant)

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Radiopaque Implanon (ro Imp)	The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate.
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.

Description

Radiopaque Implanon (ro Imp)

The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate.

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.

Participant Flow: Overall Study

	Radiopaque Implanon (ro Imp)	Implanon (Imp)
STARTED	52	56
COMPLETED	32	32
NOT COMPLETED	20	24
Adverse Event	15	17
Lost to Follow-up	1	1
Planning Pregnancy	1	4
Personal	2	2
Used prohibited medication	1	0

Baseline Characteristics

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Reporting Groups

	Description
Radiopaque Implanon (ro Imp)	The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate.
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.

Description

Radiopaque Implanon (ro Imp)

The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate.

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.

Baseline Measures

	Radiopaque Implanon (ro Imp)	Implanon (Imp)	Total
Number of Participants [units: participants]	52	56	108
Age, Customized ^[1] [units: participants]
18-20 years	11	12	23
21-25 years	9	18	27
26-30 years	15	10	25
31-35 years	6	12	18
36-40 years	10	4	14
41-45 years	1	0	1
Gender [units: participants]
Female	52	56	108
Male	0	0	0

[1]	Despite the protocol inclusion criteria, one patient was enrolled who was older than 40 years old. The subject was 43 years old.

Outcome Measures

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1. Primary:

Bioequivalence of Implanon® and Radiopaque Implanon. [ Time Frame: 3 years ]

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2. Primary:

Bioequivalence of Implanon® and Radiopaque Implanon [ Time Frame: 3 years ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: All investigator publications must be based on data validated and released by sponsor. Any such scientific paper, presentation, or other communication concerning the clinical trial will first be submitted to sponsor, at least six weeks ahead of estimated publication or presentation, for consent. In the event that no response is received within six weeks after submission, the investigator may use the submitted data.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@spcorp.com

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00620464 History of Changes
Other Study ID Numbers:	34528, P05720
Study First Received:	February 11, 2008
Results First Received:	February 17, 2010
Last Updated:	September 23, 2010
Health Authority:	France: Afssaps - French Health Products Safety Agency; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)