Effects on Bone Mineral Density (BMD) of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing LNG/EE (292005)(P05765)(COMPLETED)

This study has been completed.

Study NCT00511342 Information provided by Schering-Plough

First Received on August 2, 2007. Last Updated on October 4, 2011 History of Changes

Results First Received: July 28, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacodynamics Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Condition:	Contraception
Interventions:	Drug: NOMAC-E2 Drug: LNG-EE

Participant Flow

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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
NOMAC-E2	Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
LNG-EE	Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).

Participant Flow: Overall Study

	NOMAC-E2	LNG-EE
STARTED	56	54
COMPLETED	43	32
NOT COMPLETED	13	22
Unacceptable vaginal bleeding	2	1
Other Adverse Event (AE)/ Serious AE	8	12
Pregnancy	0	1
Pregnancy wish	0	1
Lost to Follow-up	1	5
Other Reason	2	2

Baseline Characteristics

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Reporting Groups

	Description
NOMAC-E2	Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
LNG-EE	Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).

Baseline Measures

	NOMAC-E2	LNG-EE	Total
Number of Participants [units: participants]	56	54	110
Age [units: years] Mean ± Standard Deviation	23.0 ± 3.2	22.1 ± 2.0	22.6 ± 2.7
Gender [units: participants]
Female	56	54	110
Male	0	0	0
Baseline Z-scores of the Lumbar Spine (L2-L4) and Femoral Neck ^[1] [units: score on a scale] Mean ( Full Range )
Lumbar Spine	0.351 ( -2.30 to 2.70 )	-0.106 ( -2.19 to 2.88 )	0.127 ( -2.30 to 2.88 )
Femoral Neck	0.321 ( -1.80 to 2.54 )	0.035 ( -2.44 to 2.20 )	0.181 ( -2.44 to 2.54 )

[1]	The Z-score measures the distance of the measured Bone Mineral Density (BMD) value from the appropriate normal age matched population mean value in units of standard deviation of this population. The following formula was used: Z-score= BMD value minus mean (age-matched reference population)/ SD (age-matched reference population). More negative scores indicate less BMD compared to age matched population, and more positive scores indicate higher BMD compared to age matched population.

[1]

The Z-score measures the distance of the measured Bone Mineral Density (BMD) value from the appropriate normal age matched population mean value in units of standard deviation of this population. The following formula was used:

Z-score= BMD value minus mean (age-matched reference population)/ SD (age-matched reference population).

More negative scores indicate less BMD compared to age matched population, and more positive scores indicate higher BMD compared to age matched population.

Outcome Measures

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1. Primary:

Mean Change From Baseline in Z-scores of the Lumbar Spine (L2-L4) and Femoral Neck [ Time Frame: Baseline and after cycle 26 (2 years) ]

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2. Secondary:

Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) [ Time Frame: 2 years (26 cycles) ]

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3. Secondary:

Number of Participants With an Occurrence of Breakthrough Bleeding/ Spotting [ Time Frame: Every 28-day cycle for 26 cycles (2 years total) ]

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4. Secondary:

Number of Participants With an Occurrence of Absence of Withdrawal Bleeding [ Time Frame: Every 28-day cycle for 26 cycles (2 years total) ]

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5. Secondary:

Number of Participants With an Occurrence of Breakthrough Bleeding [ Time Frame: Every 28-day cycle for 26 cycles (2 years total) ]

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6. Secondary:

Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) [ Time Frame: Every 28-day cycle for 26 cycles (2 years total) ]

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7. Secondary:

Number of Participants With an Occurrence of Early Withdrawal Bleeding [ Time Frame: Every 28-day cycle for 26 cycles (2 years total) ]

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8. Secondary:

Number of Participants With an Occurrence of Continued Withdrawal Bleeding [ Time Frame: Every 28-day cycle for 26 cycles (2 years total) including one week after stopping treatment ]

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9. Secondary:

Average Number of Breakthrough Bleeding-Spotting Days [ Time Frame: Every 28-day cycle for 26 cycles (2 years total) ]

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10. Secondary:

Average Number of Withdrawal Bleeding-spotting Days [ Time Frame: Every 28-day cycle for 26 cycles (2 years total) ]

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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: The SPONSOR recognizes the right of the investigator(s) to publish, but all publications must be based on data validated and released by the SPONSOR. Any such scientific paper, presentation, or other communication concerning the clinical trial will first be submitted to the SPONSOR, at least six weeks ahead of estimated publication or presentation, for written consent, which shall not be withheld unreasonably.

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, Group Leader
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com

No publications provided

Responsible Party:	Vice President, Late Stage Devlopment Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00511342 History of Changes
Other Study ID Numbers:	Organon Protocol No. 292005, P05765
Study First Received:	August 2, 2007
Results First Received:	July 28, 2011
Last Updated:	October 4, 2011
Health Authority:	Norway: Norwegian Medicines Agency