Efficacy and Safety of the Combined Oral Contraceptive (COC) NOMAC-E2 Compared to a COC Containing DRSP/EE (292001)(COMPLETED)(P05724)

This study has been completed.

Study NCT00511199 Information provided by Schering-Plough

First Received on August 2, 2007. Last Updated on July 28, 2011 History of Changes

Results First Received: July 28, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Condition:	Contraception
Interventions:	Drug: NOMAC-E2 Drug: DRSP-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
This study recruited participants from Europe, Asia and Australia.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In total, 2152 subjects were randomized, of which 1613 subjects to NOMAC-E2 and 539 subjects to DRSP-EE. A total of 2126 subjects were randomized and treated, of which 1591 subjects on NOMAC-E2 and 535 subjects on DRSP-EE.

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 13 consecutive 28-day menstrual cycles (1 year).
DRSP-EE	Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (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 13 consecutive 28-day menstrual cycles (1 year).

Participant Flow: Overall Study

	NOMAC-E2	DRSP-EE
STARTED	1591	535
COMPLETED	1142	410
NOT COMPLETED	449	125
Unacceptable Vaginal Bleeding	63	4
Other Adverse Event (AE)/ Serious AE	227	52
Withdrawal of Informed Consent	19	4
Pregnancy	6	3
Pregnancy Wish	16	8
Lost to Follow-up	40	17
Other Reason	78	37

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 13 consecutive 28-day menstrual cycles (1 year).
DRSP-EE	Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (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 13 consecutive 28-day menstrual cycles (1 year).

Baseline Measures

	NOMAC-E2	DRSP-EE	Total
Number of Participants [units: participants]	1591	535	2126
Age [units: years] Mean ± Standard Deviation	28.1 ± 7.0	27.6 ± 7.0	28.0 ± 7.0
Gender [units: participants]
Female	1591	535	2126
Male	0	0	0

Outcome Measures

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1. Primary:

Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) [ Time Frame: 1 year (13 cycles) ]

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2. Primary:

Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index) [ Time Frame: 1 year (13 cycles) ]

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3. Secondary:

Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting [ Time Frame: Every 28-day cycle for 13 cycles (one year 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 13 cycles (one year total) ]

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5. Secondary:

Number of Participants With an Occurrence of Breakthrough Bleeding [ Time Frame: Every 28-day cycle for 13 cycles (one year 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 13 cycles (one year total) ]

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7. Secondary:

Number of Participants With an Occurrence of Early Withdrawal Bleeding [ Time Frame: Every 28-day cycle for 13 cycles (one year total) ]

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8. Secondary:

Number of Participants With an Occurrence of Continued Withdrawal Bleeding [ Time Frame: Every 28-day cycle for 12 cycles ]

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9. Secondary:

Average Number of Breakthrough Bleeding/Spotting Days [ Time Frame: Every 28-day cycle for 13 cycles (one year total) ]

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10. Secondary:

Average Number of Withdrawal Bleeding/Spotting Days [ Time Frame: Every 28-day cycle for 13 cycles (one year 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 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 of Late Stage Development, Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00511199 History of Changes
Other Study ID Numbers:	Organon Protocol No. 292001, P05724
Study First Received:	August 2, 2007
Results First Received:	July 28, 2011
Last Updated:	July 28, 2011
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)