Efficacy and Safety Study of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292002)(COMPLETED)(P05722)

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00413062

First received: December 18, 2006

Last updated: March 27, 2013

Last verified: March 2013

History of Changes

Results First Received: April 27, 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 North America and South America

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In total, 2281 participants were randomized (NOMAC-E2 n=1710; DRSP-EE n=571) but 2220 participants were treated (NOMAC-E2 n=1666; DRSP-EE n=554).

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	1666	554
COMPLETED	988	344
NOT COMPLETED	678	210
Adverse event/serious adverse event	289	56
Pre-treatment (serious) adverse event	1	0
Withdrawal of informed consent	111	36
Pregnancy	15	5
Pregnancy wish	17	6
Lost to Follow-up	175	73
Other reason	70	34

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).
Total	Total of all reporting groups

Baseline Measures

	NOMAC-E2	DRSP-EE	Total
Number of Participants [units: participants]	1666	554	2220
Age [units: years] Mean ± Standard Deviation	27.6 ± 7.2	27.8 ± 7.0	27.7 ± 7.1
Gender [units: participants]
Female	1666	554	2220
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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Measure Type	Secondary
Measure Title	Number of Participants With an Occurrence of Early Withdrawal Bleeding
Measure Description	Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Early withdrawal bleeding was defined as any withdrawal bleeding that started before the current "expected bleeding period". Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.
Time Frame	Every 28-day cycle for 13 cycles (one year total)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length. n= number of participants with evaluable cycles.

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.

n= number of participants with evaluable cycles.

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).

Measured Values

	NOMAC-E2	DRSP-EE
Number of Participants Analyzed [units: participants]	1312	436
Number of Participants With an Occurrence of Early Withdrawal Bleeding [units: participants]
Cycle 1 (n=1202 NOMAC-E2; n=398 DRSP-EE)	175	46
Cycle 2 (n=950 NOMAC-E2; n=308 DRSP-EE)	68	14
Cycle 3 (n=812 NOMAC-E2; n=256 DRSP-EE)	66	24
Cycle 4 (n=739 NOMAC-E2; n=236 DRSP-EE)	48	9
Cycle 5 (n=671 NOMAC-E2; n=229 DRSP-EE)	36	11
Cycle 6 (n=628 NOMAC-E2; n=207 DRSP-EE)	28	11
Cycle 7 (n=565 NOMAC-E2; n=196 DRSP-EE)	22	11
Cycle 8 (n=543 NOMAC-E2; n=189 DRSP-EE)	29	13
Cycle 9 (n=507 NOMAC-E2; n=173 DRSP-EE)	17	9
Cycle 10 (n=491 NOMAC-E2; n=170 DRSP-EE)	27	13
Cycle 11 (n=456 NOMAC-E2; n=160 DRSP-EE)	17	7
Cycle 12 (n=428 NOMAC-E2; n=152 DRSP-EE)	10	6
Cycle 13 (n=383 NOMAC-E2; n=133 DRSP-EE)	9	6

No statistical analysis provided for Number of Participants With an Occurrence of Early Withdrawal Bleeding

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
No text entered.

Results Point of Contact:

Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp.
e-mail: ClinicalTrialsDisclosure@merck.com

No publications provided by Merck

Publications automatically indexed to this study:

Westhoff C, Kaunitz AM, Korver T, Sommer W, Bahamondes L, Darney P, Verhoeven C. Efficacy, safety, and tolerability of a monophasic oral contraceptive containing nomegestrol acetate and 17β-estradiol: a randomized controlled trial. Obstet Gynecol. 2012 May;119(5):989-99.

Responsible Party:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00413062 History of Changes
Other Study ID Numbers:	Organon protocol 292002, P05722
Study First Received:	December 18, 2006
Results First Received:	April 27, 2011
Last Updated:	March 27, 2013
Health Authority:	United States: Food and Drug Administration

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