Trial · NCT00511355

Effects on Hemostasis, Lipids, Carbohydrate Metabolism, Adrenal & Thyroid Function of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing LNG-EE (292004)(COMPLETED)(P05764)

NCT00511355, Phase 3, Completed, Organon and Co; results first posted 2011-08-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effects on Hemostasis, Lipids, Carbohydrate Metabolism, Adrenal & Thyroid Function of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing LNG-EE (292004)(COMPLETED)(P05764). Trials, record NCT00511355. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00511355

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effects on Hemostasis, Lipids, Carbohydrate Metabolism, Adrenal & Thyroid Function of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing LNG-EE (292004)(COMPLETED)(P05764)
NCT number: NCT00511355
Status: Completed
Phases: Phase 3
Enrollment: 121 participants, actual
Lead sponsor: Organon and Co
Conditions: Contraception
Interventions: NOMAC-E2, Levonorgestrel and Ethinyl Estradiol
First posted: 2007-08-03
Last updated: 2022-02-09
Results first posted: 2011-08-30

Source ClinicalTrials.gov

Registered outcomes47

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Serum Concentration of Prothrombin Fragments 1 + 2	Baseline and Cycle 6 (between Days 15 and 21 of the cycle)	Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Primary	Serum Concentration of D-Dimer	Baseline and Cycle 6 (between Days 15 and 21 of the cycle)	Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Primary	Activated Protein C (APC) Resistance Ratio (Endogenous Thrombin Potential [ETP]-Based)	Baseline and Cycle 6 (between Days 15 and 21 of the cycle)	Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). APC resistance ratio (ETP-based) measures the anticoagulation response of plasma to APC after activation of the extrinsic coagulation pathway. An increase in the ratio indicates a reduced responsiveness to APC. Each cycle consists of 28 days.
Primary	Serum Concentration of Clotting Factor VIIa	Baseline and Cycle 6 (between Days 15 and 21 of the cycle)	Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Primary	Serum Concentration of Clotting Factor VIIc	Baseline and Cycle 6 (between Days 15 and 21 of the cycle)	Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Primary	Serum Concentration of Clotting Factor VIII	Baseline and Cycle 6 (between Days 15 and 21 of the cycle)	Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Primary	Serum Concentration of Clotting Factor II	Baseline and Cycle 6 (between Days 15 and 21 of the cycle)	Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Primary	Serum Concentration of Antithrombin III	Baseline and Cycle 6 (between Days 15 and 21 of the cycle)	Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Primary	Serum Concentration of Protein S (Free)	Baseline and Cycle 6 (between Days 15 and 21 of the cycle)	Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Primary	Serum Concentration of Protein S (Total)	Baseline and Cycle 6 (between Days 15 and 21 of the cycle)	Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.

1 to 10 of 47Source ClinicalTrials.gov

See all 47 registered outcomes

Outcomes47

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Serum Concentration of Prothrombin Fragments 1 + 2	Baseline and Cycle 6 (between Days 15 and 21 of the cycle)	All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6	nmol/L	MEAN
PRIMARY	Serum Concentration of D-Dimer	Baseline and Cycle 6 (between Days 15 and 21 of the cycle)	All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6	mg/L Fibrinogen Equivalent Units (FEU)	MEAN
PRIMARY	Activated Protein C (APC) Resistance Ratio (Endogenous Thrombin Potential [ETP]-Based)	Baseline and Cycle 6 (between Days 15 and 21 of the cycle)	All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6	Ratio	MEAN
PRIMARY	Serum Concentration of Clotting Factor VIIa	Baseline and Cycle 6 (between Days 15 and 21 of the cycle)	All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6	U/L	MEAN
PRIMARY	Serum Concentration of Clotting Factor VIIc	Baseline and Cycle 6 (between Days 15 and 21 of the cycle)	All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6	Percent of normal	MEAN
SECONDARY	Serum Concentration of Total Testosterone	Baseline and Cycle 6 (between Days 15 and 21 of the cycle)	All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6	nmol/L	MEAN
SECONDARY	Serum Concentration of Free Testosterone	Baseline and Cycle 6 (between Days 15 and 21 of the cycle)	All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6	pmol/L	MEAN
SECONDARY	Serum Concentration of Dehydroepiandrosterone Sulphate (DHEAS)	Baseline and Cycle 6 (between Days 15 and 21 of the cycle)	All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6	umol/L	MEAN
PRIMARY	Serum Concentration of Clotting Factor VIII	Baseline and Cycle 6 (between Days 15 and 21 of the cycle)	All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6	Percent of normal	MEAN
PRIMARY	Serum Concentration of Clotting Factor II	Baseline and Cycle 6 (between Days 15 and 21 of the cycle)	All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6	Percent of normal	MEAN

1 to 10 of 47Source ClinicalTrials.gov

See all 47 outcomes

Results by group248

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Serum Concentration of Prothrombin Fragments 1 + 2	NOMAC-E2	Baseline (n=60 NOMAC-E2; n=58 LNG-EE)	0.18	Standard Deviation 0.20	nmol/L
Serum Concentration of Prothrombin Fragments 1 + 2	LNG-EE	Baseline (n=60 NOMAC-E2; n=58 LNG-EE)	0.19	Standard Deviation 0.08	nmol/L
Serum Concentration of Prothrombin Fragments 1 + 2	NOMAC-E2	Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE)	0.31	Standard Deviation 1.06	nmol/L
Serum Concentration of Prothrombin Fragments 1 + 2	LNG-EE	Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE)	0.42	Standard Deviation 1.17	nmol/L
Serum Concentration of D-Dimer	NOMAC-E2	Baseline (n=60; NOMAC-E2; n=58)	0.21	Standard Deviation 0.16	mg/L Fibrinogen Equivalent Units (FEU)
Serum Concentration of D-Dimer	LNG-EE	Baseline (n=60; NOMAC-E2; n=58)	0.19	Standard Deviation 0.14	mg/L Fibrinogen Equivalent Units (FEU)
Serum Concentration of D-Dimer	NOMAC-E2	Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE)	0.18	Standard Deviation 0.14	mg/L Fibrinogen Equivalent Units (FEU)
Serum Concentration of D-Dimer	LNG-EE	Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE)	0.26	Standard Deviation 0.21	mg/L Fibrinogen Equivalent Units (FEU)
Activated Protein C (APC) Resistance Ratio (Endogenous Thrombin Potential [ETP]-Based)	NOMAC-E2	Baseline (n=59 NOMAC-E2; n=58 LNG-EE)	0.80	Standard Deviation 0.33	Ratio
Activated Protein C (APC) Resistance Ratio (Endogenous Thrombin Potential [ETP]-Based)	LNG-EE	Baseline (n=59 NOMAC-E2; n=58 LNG-EE)	0.83	Standard Deviation 0.40	Ratio

1 to 10 of 248Source ClinicalTrials.gov

See all 248 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	NOMAC-E2	60
Overall Study	STARTED	LNG-EE	61
Overall Study	COMPLETED	NOMAC-E2	53
Overall Study	COMPLETED	LNG-EE	52
Overall Study	NOT COMPLETED	NOMAC-E2	7
Overall Study	NOT COMPLETED	LNG-EE	9

Source ClinicalTrials.gov

Adverse events10

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Influenza	Infections and infestations	NOMAC-E2	1	60	1
other	Influenza	Infections and infestations	LNG-EE	4	58	4
other	Upper respiratory tract infection	Infections and infestations	NOMAC-E2	6	60	14
other	Upper respiratory tract infection	Infections and infestations	LNG-EE	5	58	6
other	Headache	Nervous system disorders	NOMAC-E2	3	60	5
other	Headache	Nervous system disorders	LNG-EE	7	58	14
other	Acne	Skin and subcutaneous tissue disorders	NOMAC-E2	2	60	2
other	Acne	Skin and subcutaneous tissue disorders	LNG-EE	4	58	4
serious	Congenital mitral valve incompetence	Congenital, familial and genetic disorders	NOMAC-E2	1	60	1
serious	Congenital mitral valve incompetence	Congenital, familial and genetic disorders	LNG-EE	0	58	0

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	NOMAC-E2
Total, all-cause mortality	LNG-EE
Total, other adverse events	NOMAC-E2	9	60
Total, other adverse events	LNG-EE	18	58
Total, serious adverse events	NOMAC-E2	1	60
Total, serious adverse events	LNG-EE	0	58

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22066891	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
NOMAC-E2 vs LNG-EE: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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