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Study of the Contraceptive Efficacy and Safety of a NOMAC-E2 Combined Oral Contraceptive (COC)(P06448)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01656434
Recruitment Status : Terminated (Business reasons)
First Posted : August 3, 2012
Results First Posted : March 17, 2015
Last Update Posted : February 3, 2022
Sponsor:
Information provided by (Responsible Party):
Organon and Co

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Contraception
Interventions Drug: NOMAC-E2
Drug: NETA-EE
Other: Placebo
Drug: ethinylestradiol (EE)
Drug: ferrous fumarate
Enrollment 3173
Recruitment Details  
Pre-assignment Details  
Arm/Group Title NOMAC-E2 NETA-EE
Hide Arm/Group Description Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28. Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
Period Title: Overall Study
Started 2553 620
Treated 2466 [1] 604
Completed 152 40
Not Completed 2401 580
Reason Not Completed
Adverse Event             199             63
Enrollment terminated at trial site             2             0
Lost to Follow-up             309             76
Site discontinued study participation             24             9
Screen failure             2             0
Protocol Violation             7             0
Pregnancy wish             18             6
Pregnancy             45             10
Physician Decision             7             2
Non-compliance with study drug             48             9
Study terminated by sponsor             1501             348
Participant discontinued; drug related             13             4
Part. discontinued; unrelated to drug             55             10
Non-compliance with protocol             39             15
Participant moved             40             12
Participant withdrew consent             28             9
Withdrawal by Subject             64             7
[1]
One treated participant had incomplete data and was not included in the Safety Analyses.
Arm/Group Title NOMAC-E2 NETA-EE Total
Hide Arm/Group Description Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28. Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28. Total of all reporting groups
Overall Number of Baseline Participants 2466 604 3070
Hide Baseline Analysis Population Description
All Subjects as Treated Population, which consisted of all randomized participants who took at least one dose of trial medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2466 participants 604 participants 3070 participants
29.2  (7.6) 29.5  (7.7) 29.3  (7.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2466 participants 604 participants 3070 participants
Female
2466
 100.0%
604
 100.0%
3070
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of In-Treatment Pregnancies Per 100 Woman Years of Exposure (Pearl Index)
Hide Description Primary Efficacy Outcome measure for this study was contraceptive efficacy, or the prevention of in-treatment pregnancy. The total incidence of in-treatment pregnancies was expressed as the Pearl Index, which is defined as the number of in-treatment pregnancies per 100 woman-years of exposure.
Time Frame Up to 1 year (13 cycles)
Hide Outcome Measure Data
Hide Analysis Population Description
Planned analysis for this primary endpoint was not performed due to early study termination.
Arm/Group Title NOMAC-E2 NETA-EE
Hide Arm/Group Description:
Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Percentage of Participants With an Occurrence of Breakthrough Bleeding/Spotting
Hide Description Participants kept e-diaries to record their vaginal bleeding events. They were asked to record, on a daily basis, whether they experienced vaginal bleeding, which included BLEEDING or SPOTTING, at any time during a cycle other than normal menstruation while in the study. (This is also known as "breakthough" bleeding.) Vaginal bleeding that required >=1 pad/tampon per day was classified as BLEEDING. Vaginal bleeding that did not require a pad/tampon per day was classified as SPOTTING.
Time Frame Up to 1 year (13 cycles)
Hide Outcome Measure Data
Hide Analysis Population Description
Planned analysis for this secondary endpoint was not performed due to early study termination.
Arm/Group Title NOMAC-E2 NETA-EE
Hide Arm/Group Description:
Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Percentage of Participants With an Absence of Withdrawal Bleeding
Hide Description Participants kept e-diaries to record vaginal bleeding events. They were asked to record, on a daily basis, whether vaginal bleeding was present. Absence of withdrawal bleeding was defined as no bleeding/spotting during the expected bleeding period.
Time Frame Up to 1 year (13 cycles)
Hide Outcome Measure Data
Hide Analysis Population Description
Planned analysis for this secondary endpoint was not performed due to early study termination.
Arm/Group Title NOMAC-E2 NETA-EE
Hide Arm/Group Description:
Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Percentage of Participants Who Experienced At Least One Adverse Event
Hide Description An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
Time Frame Up to 54 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects as Treated Population, which consisted of all randomized participants who took at least one dose of trial medication. One treated participant in the NOMAC-E2 treatment group had incomplete data and was not included in the Safety Analyses.
Arm/Group Title NOMAC-E2 NETA-EE
Hide Arm/Group Description:
Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
Overall Number of Participants Analyzed 2465 604
Measure Type: Number
Unit of Measure: Percentage of Participants
41.2 45.2
5.Secondary Outcome
Title Number of Participants Who Experience at Least One Venous or Arterial Thrombotic/Thromboembolic Event
Hide Description [Not Specified]
Time Frame Up to 54 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects as Treated Population, which consisted of all randomized participants who took at least one dose of trial medication. One treated participant in the NOMAC-E2 treatment group had incomplete data and was not included in the Safety Analyses.
Arm/Group Title NOMAC-E2 NETA-EE
Hide Arm/Group Description:
Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
Overall Number of Participants Analyzed 2465 604
Measure Type: Number
Unit of Measure: Participants
0 1
6.Secondary Outcome
Title Change From Baseline in Body Weight
Hide Description Participants' body weights were measured in a consistent manner throughout the trial, using standardized equirpment. Last In-Treatment Measurement refers to a participant's end of trial visit, the timing of which differed among participants.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from All Subjects as Treated Population (all randomized participants who took at least one dose of trial medication) who had data available for Change from Baseline in Body Weight endpoint.
Arm/Group Title NOMAC-E2 NETA-EE
Hide Arm/Group Description:
Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
Overall Number of Participants Analyzed 2231 549
Mean (Standard Error)
Unit of Measure: kilograms
After Cycle 3 (n=2135; n=527) 0.14  (0.14) 0.41  (0.24)
After Cycle 6 (n=1809; n=459) 0.64  (0.18) 0.29  (0.28)
After Cycle 9 (n=1468; n=391) 1.21  (0.23) 0.32  (0.35)
After Cycle 13 (n=462; n=145) 1.57  (0.29) 0.90  (0.46)
Last In-Treatment Measurement (n=2231; n=549) 1.39  (0.17) 0.75  (0.29)
Time Frame Up to 54 weeks
Adverse Event Reporting Description All Subjects as Treated Population, which consisted of all randomized participants who took at least one dose of trial medication. One treated participant in the NOMAC-E2 treatment group had incomplete data and was not included in the Safety Analyses.
 
Arm/Group Title NOMAC-E2 NETA-EE
Hide Arm/Group Description Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28. Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
All-Cause Mortality
NOMAC-E2 NETA-EE
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
NOMAC-E2 NETA-EE
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/2465 (0.81%)      8/604 (1.32%)    
Gastrointestinal disorders     
Internal hernia † 1  0/2465 (0.00%)  0 1/604 (0.17%)  1
Irritable bowel syndrome † 1  1/2465 (0.04%)  1 0/604 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis chronic † 1  1/2465 (0.04%)  1 0/604 (0.00%)  0
Immune system disorders     
Anaphylactic reaction † 1  1/2465 (0.04%)  1 0/604 (0.00%)  0
Infections and infestations     
Bacterial pyelonephritis † 1  0/2465 (0.00%)  0 1/604 (0.17%)  1
Breast cellulitis † 1  0/2465 (0.00%)  0 1/604 (0.17%)  1
Cellulitis † 1  1/2465 (0.04%)  1 0/604 (0.00%)  0
Pelvic inflammatory disease † 1  1/2465 (0.04%)  1 0/604 (0.00%)  0
Pneumonia † 1  1/2465 (0.04%)  1 0/604 (0.00%)  0
Tubo-ovarian abscess † 1  1/2465 (0.04%)  1 0/604 (0.00%)  0
Injury, poisoning and procedural complications     
Concussion † 1  0/2465 (0.00%)  0 1/604 (0.17%)  1
Fibula fracture † 1  0/2465 (0.00%)  0 1/604 (0.17%)  1
Humerus fracture † 1  1/2465 (0.04%)  1 0/604 (0.00%)  0
Rib fracture † 1  1/2465 (0.04%)  1 0/604 (0.00%)  0
Traumatic haemothorax † 1  0/2465 (0.00%)  0 1/604 (0.17%)  1
Traumatic liver injury † 1  0/2465 (0.00%)  0 1/604 (0.17%)  1
Metabolism and nutrition disorders     
Diabetic ketoacidosis † 1  1/2465 (0.04%)  1 0/604 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Epiphysiolysis † 1  1/2465 (0.04%)  1 0/604 (0.00%)  0
Muscular weakness † 1  1/2465 (0.04%)  1 0/604 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Ovarian fibroma † 1  1/2465 (0.04%)  1 0/604 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous † 1  0/2465 (0.00%)  0 1/604 (0.17%)  1
Abortion spontaneous complete † 1  1/2465 (0.04%)  1 0/604 (0.00%)  0
Ectopic pregnancy † 1  1/2465 (0.04%)  1 1/604 (0.17%)  1
Foetal death † 1  0/2465 (0.00%)  0 1/604 (0.17%)  1
Psychiatric disorders     
Depression † 1  2/2465 (0.08%)  2 0/604 (0.00%)  0
Mental status changes † 1  0/2465 (0.00%)  0 1/604 (0.17%)  1
Suicidal ideation † 1  0/2465 (0.00%)  0 1/604 (0.17%)  1
Substance abuse † 1  1/2465 (0.04%)  1 0/604 (0.00%)  0
Renal and urinary disorders     
Nephrolithiasis † 1  1/2465 (0.04%)  1 0/604 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Asthma † 1  1/2465 (0.04%)  1 0/604 (0.00%)  0
Pulmonary embolism † 1  0/2465 (0.00%)  0 1/604 (0.17%)  1
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
NOMAC-E2 NETA-EE
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2465 (0.00%)      0/604 (0.00%)    
[Not Specified]
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 investigator agrees to provide to the Sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication (including slides and texts of oral or other public presentations that report any results of the trial). The Sponsor has the right to review and comment on publications, abstracts, slides, and manuscripts, as well as the data analysis and presentation.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Organon and Co
ClinicalTrials.gov Identifier: NCT01656434    
Other Study ID Numbers: P06448
MK-8175A-022 ( Other Identifier: Merck Protocol Number )
SCH 900121 P06448 ( Other Identifier: Merck Protocol ID )
First Submitted: July 31, 2012
First Posted: August 3, 2012
Results First Submitted: February 9, 2015
Results First Posted: March 17, 2015
Last Update Posted: February 3, 2022