Effects on Ovarian Function of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292003)(COMPLETED)(P05723)

This study has been completed.

Sponsor:

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00511433

First received: August 2, 2007

Last updated: July 28, 2011

Last verified: July 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: 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
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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 6 consecutive 28-day menstrual cycles.
DRSP-EE	Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol 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 6 consecutive 28-day menstrual cycles.

Participant Flow: Overall Study

	NOMAC-E2	DRSP-EE
STARTED	32	16
COMPLETED	26	15
NOT COMPLETED	6	1
Adverse Event	5	0
Other Reason	1	1

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 6 consecutive 28-day menstrual cycles.
DRSP-EE	Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol 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 6 consecutive 28-day menstrual cycles.
Total	Total of all reporting groups

Baseline Measures

	NOMAC-E2	DRSP-EE	Total
Number of Participants [units: participants]	32	16	48
Age [units: years] Mean ± Standard Deviation	22.8 ± 3.3	22.9 ± 4.3	22.8 ± 3.6
Gender [units: participants]
Female	32	16	48
Male	0	0	0

Outcome Measures

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1. Primary:

Effect on Ovarian Function as Determined by the Number of Participants With an Occurrence of Ovulation [ Time Frame: Cycle 1, Cycle 2, and Cycle 6 ]

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2. Primary:

Effect on Ovarian Function as Determined by the Maximum Follicle Diameter [ Time Frame: Screening cycle, Cycle 1, Cycle 2, Cycle 3, and Cycle 6 ]

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3. Primary:

Effect on Ovarian Function as Determined by the Maximum Progesterone Value [ Time Frame: Screening cycle, Cycle 1, Cycle 2, Cycle 3, and Cycle 6 ]

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4. Primary:

Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) [ Time Frame: Cycle 1, Cycle 2, Cycle 3, and Cycle 6 ]

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5. Primary:

Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) [ Time Frame: Cycle 1, Cycle 2, Cycle 3, and Cycle 6 ]

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6. Primary:

Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) [ Time Frame: Cycle 1, Cycle 2, Cycle 3, and Cycle 6 ]

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7. Secondary:

Effect on Cervical Mucus as Determined by Insler Score [ Time Frame: Screening Cycle, Cycle 1, Cycle 2, and Cycle 7 (post-treatment cycle) ]

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8. Secondary:

Effect on Maximum Endometrial Thickness [ Time Frame: Screening Cycle, Cycle 1, Cycle 2, and Cycle 6 ]

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9. Secondary:

Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) [ Time Frame: 6 cycles ]

Show Outcome Measure 9

10. Secondary:

Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting [ Time Frame: Every 28-day cycle for 6 cycles ]

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11. Secondary:

Number of Participants With an Occurrence of Absence of Withdrawal Bleeding [ Time Frame: Every 28-day cycle for 6 cycles ]

Show Outcome Measure 11

12. Secondary:

Number of Participants With an Occurrence of Breakthrough Bleeding [ Time Frame: Every 28-day cycle for 6 cycles ]

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13. Secondary:

Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) [ Time Frame: Every 28-day cycle for 6 cycles ]

Show Outcome Measure 13

14. Secondary:

Number of Participants With an Occurrence of Early Withdrawal Bleeding [ Time Frame: Every 28-day cycle for 6 cycles ]

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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 diary card booklets. 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: 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 6 cycles
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 6 consecutive 28-day menstrual cycles.
DRSP-EE	Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol 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 6 consecutive 28-day menstrual cycles.

Measured Values

	NOMAC-E2	DRSP-EE
Number of Participants Analyzed [units: participants]	30	16
Number of Participants With an Occurrence of Early Withdrawal Bleeding [units: Participants]
Cycle 1 (n=30 NOMAC-E2 / n=16 DRSP-EE)	4	2
Cycle 2 (n=27 NOMAC-E2 / n=16 DRSP-EE)	4	0
Cycle 3 (n=26 NOMAC-E2 / n=15 DRSP-EE)	1	0
Cycle 4 (n=26 NOMAC-E2 / n=15 DRSP-EE)	2	0
Cycle 5 (n=26 NOMAC-E2 / n=15 DRSP-EE)	1	0
Cycle 6 (n=26 NOMAC-E2 / n=14 DRSP-EE)	2	0

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

15. Secondary:

Number of Participants With an Occurrence of Continued Withdrawal Bleeding [ Time Frame: Every 28-day cycle for 5 cycles ]

Show Outcome Measure 15

16. Secondary:

Average Number of Breakthrough Bleeding/Spotting Days [ Time Frame: Every 28-day cycle for 6 cycles ]

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17. Secondary:

Average Number of Withdrawal Bleeding Days [ Time Frame: Every 28-day cycle for 6 cycles ]

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

No publications provided

Responsible Party:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00511433 History of Changes
Other Study ID Numbers:	Organon protocol 292003, P05723
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)

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