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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)
This study has been completed.

First Received on August 2, 2007.   Last Updated on October 10, 2011   History of Changes
Sponsor: Schering-Plough
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT00511355
  Purpose

The primary purpose of this study is to evaluate the effects of the combined oral contraceptive (COC) NOMAC-E2 on hemostasis, lipids, carbohydrate metabolism, adrenal function, and thyroid function.


Condition Intervention Phase
Contraception
 Drug: NOMAC-E2
Drug: Levonorgestrel and Ethinyl Estradiol
 Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomized, Open-Label, Comparative, Multi -Center Trial to Evaluate the Effects on Hemostasis, Lipids and Carbohydrate Metabolism, and on Adrenal and Thyroid Function of a Monophasic COC Containing 2.5 mg NOMAC and 1.5 mg E2 Compared to a Monophasic COC Containing 150 ug LNG and 30 ug EE

Resource links provided by NLM:

MedlinePlus related topics: Birth Control Cholesterol Diabetes Medicines Thyroid Diseases
Drug Information available for: Estradiol Estradiol 3-benzoate Ethinyl estradiol Polyestradiol phosphate Depogen Lipids Estradiol dipropionate Estradiol cypionate Levonorgestrel Estradiol valerate Estradiol acetate Thyroid
U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Serum Concentration of Prothrombin Fragments 1 + 2 [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.

  • Serum Concentration of D-Dimer [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.

  • Activated Protein C (APC) Resistance Ratio (Endogenous Thrombin Potential [ETP]-Based) [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    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.

  • Serum Concentration of Clotting Factor VIIa [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.

  • Serum Concentration of Clotting Factor VIIc [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.

  • Serum Concentration of Clotting Factor VIII [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.

  • Serum Concentration of Clotting Factor II [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.

  • Serum Concentration of Antithrombin III [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.

  • Serum Concentration of Protein S (Free) [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.

  • Serum Concentration of Protein S (Total) [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.

  • Serum Concentration of Protein C [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.

  • APC Resistance Ratio (Activated Partial Thromboplastin Time [APTT]-Based) [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). APC resistance ratio (APTT-based) measures the anticoagulation response of plasma to APC after activation of the intrinsic coagulation pathway. An increase in the ratio indicates a increased responsiveness to APC. Each cycle consists of 28 days.

  • Serum Concentration of Sex Hormone Binding Globulin (SHBG) [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.

  • Serum Concentration of C-Reactive Protein (CRP) [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.

  • Serum Concentration of Total Cholesterol [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.

  • Serum Concentration of High Density Lipoprotein (HDL)-Cholesterol [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.

  • Serum Concentration of HDL2-cholesterol [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.

  • Serum Concentration of HDL3-cholesterol [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.

  • Serum Concentration of Low Density Lipoprotein (LDL)-Cholesterol [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.

  • Serum Concentration of Apolipoprotein A-1 [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.

  • Serum Concentration of Apolipoprotein B [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.

  • Serum Concentration of Lipoprotein(a) [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.

  • Serum Concentration of Total Triglycerides [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.

  • Area Under the Curve Over 3 Hours (AUC3) for Glucose (Oral Glucose Tolerance Test [OGTT]) [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Blood glucose levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Each cycle consists of 28 days.

  • Incremental AUC3 for Glucose (OGTT) [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Blood glucose levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Incremental area under the curve was defined as incremental AUC3 = AUC3 - 3*fasting concentration. Each cycle consists of 28 days.

  • AUC3 for Insulin (OGTT) [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Blood insulin levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Each cycle consists of 28 days.

  • Incremental AUC3 for Insulin (OGTT) [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Blood insulin levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Incremental area under the curve was defined as incremental AUC3 = AUC3 - 3*fasting concentration. Each cycle consists of 28 days.

  • Serum Concentration of Hemoglobin Type A1c (HbA1c) [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). HbA1c was determined before glucose loading. Each cycle consists of 28 days.

  • Serum Concentration of Total Cortisol [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.

  • Serum Concentration of Corticosteroid Binding Globulin (CBG) [ Time Frame: Baseline to Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.

  • Serum Concentration of Thyroid Stimulating Hormone (TSH) [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.

  • Serum Concentration of Free Thyroxine (T4) [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.

  • Serum Concentration of Thyroxin Binding Globulin (TBG) [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.


Secondary Outcome Measures:
  • Serum Concentration of Total Testosterone [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.

  • Serum Concentration of Free Testosterone [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.

  • Serum Concentration of Dehydroepiandrosterone Sulphate (DHEAS) [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.

  • Serum Concentration of Androstenedione [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.

  • Serum Concentration of Dihydrotestosterone (DHT) [ Time Frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle) ] [ Designated as safety issue: Yes ]
    Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.

  • Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) [ Time Frame: 6 cycles ] [ Designated as safety issue: No ]
    In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a maximum of 2 days. Each 13 cycles (28 days per cycle) constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant.

  • Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting [ Time Frame: Every 28-day cycle for 6 cycles ] [ Designated as safety issue: No ]
    Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the "expected non-bleeding period" that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle.

  • Number of Participants With an Occurrence of Absence of Withdrawal Bleeding [ Time Frame: Every 28-day cycle for 6 cycles ] [ Designated as safety issue: No ]
    Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Absence of withdrawal bleeding was defined as no bleeding/spotting episode that began during or continued into the "expected bleeding period". Expected bleeding period: NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle; LNG-EE: 7-day period starting on Day 22 of the cycle.

  • Number of Participants With an Occurrence of Breakthrough Bleeding [ Time Frame: Every 28-day cycle for 6 cycles ] [ Designated as safety issue: No ]
    Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding was defined as any bleeding episode that occurred during the "expected non-bleeding period" that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle.

  • Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) [ Time Frame: Every 28-day cycle for 6 cycles ] [ Designated as safety issue: No ]
    Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough spotting was defined as any spotting episode that occurred during the "expected non-bleeding period" that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle.

  • Number of Participants With an Occurrence of Early Withdrawal Bleeding [ Time Frame: Every 28-day cycle for 6 cycles ] [ Designated as safety issue: No ]
    Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary 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: NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle; LNG-EE: 7-day period starting on Day 22 of the cycle.

  • Number of Participants With an Occurrence of Continued Withdrawal Bleeding [ Time Frame: Every 28-day cycle for 5 cycles ] [ Designated as safety issue: No ]
    Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Continued withdrawal bleeding was defined as any withdrawal bleeding that continued into the "expected non-bleeding period" of the next cycle. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle.

  • Average Number of Breakthrough Bleeding/Spotting Days [ Time Frame: Every 28-day cycle for 6 cycles ] [ Designated as safety issue: No ]
    Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the "expected non-bleeding period" that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle.

  • Average Number of Withdrawal Bleeding/Spotting Days [ Time Frame: Every 28-day cycle for 6 cycles ] [ Designated as safety issue: No ]
    Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Withdrawal bleeding/spotting was defined as any episode that occurred during the "expected bleeding period". Expected bleeding period: NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle; LNG-EE: 7-day period starting on Day 22 of the cycle.


Enrollment: 121
Study Start Date: September 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NOMAC-E2
Nomegestrol Acetate (NOMAC) and Estradiol (E2), 2.5 mg NOMAC and 1.5 mg E2 monophasic combined oral contraceptive
 Drug: NOMAC-E2
Nomegestrol Acetate and Estradiol (NOMAC-E2) Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day cycles.
Other Names:
  • SCH 900121
  • Org 10486-0 (NOMAC)
  • Org 2317 (E2)
Active Comparator: LNG-EE
Levonorgestrel and Ethinyl Estradiol Tablets (LNG-EE), 150 mcg LNG and 30 mcg EE
 Drug: Levonorgestrel and Ethinyl Estradiol
Levonorgestrel and Ethinyl Estradiol (LNG-EE) Tablets, 150 mcg LNG and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day cycles.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Sexually active women, at risk for pregnancy and not planning to use during trial medication use;
  • Women in need for contraception and willing to use an oral contraceptive (OC) for 6 months (6 cycles);
  • At least 18 but not older than 50 years of age at the time of screening;
  • Body mass index = 17 and = 29 kg/m^2;
  • Good physical and mental health;
  • Willing to give informed consent in writing

Exclusion Criteria:

  • Present use or use within 2 months prior to screening of any other hormonal treatment including sex hormones (other than contraceptives), insulin, thyroid and corticosteroid hormones (with the exception for local dermatological use);
  • Contraindications for contraceptive steroids
  • Presence or history (within 1 year before screening) of alcohol or drug abuse as judged by the (sub)investigator.
  • An abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia [CIN], SIL, carcinoma in situ, invasive carcinoma) at screening or documentation of an abnormal smear performed within 6 months before screening;
  • Clinically relevant abnormal laboratory result at screening as judged by the (sub) investigator;
  • Use of an injectable hormonal method of contraception prior to screening; within 6 months of an injection with a 3 -month duration, within 4 months to screening of an injection with a 2-month duration, within 2 months of an injection with a 1-month duration;
  • Before spontaneous menstruation has occurred following a delivery or abortion;
  • Breastfeeding or within 2 months after stopping breastfeeding prior to the start of trial medication;
  • Present use or use within 2 months prior to the start of the trial medication of the following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, lipid-lowering drugs, anticoagulants and herbal remedies containing Hypericum perforatum (St John's Wort);
  • Use of pharmacological agents which affect the hemostatic system during the pretreatment blood sampling: vitamin K (only prohibited within two weeks prior to sampling), nonsteroidal anti-inflammatory drugs (NSAIDS) and aspirin (both only prohibited during the week prior to sampling);
  • Administration of investigational drugs and/or participation in another clinical trial within 2 months prior to the start of the trial medication or during the trial period.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00511355     History of Changes
Other Study ID Numbers: Organon Protocol No. 292004, P05764
Study First Received: August 2, 2007
Results First Received: July 28, 2011
Last Updated: October 10, 2011
Health Authority: Finland: Finnish Medicines Agency

Additional relevant MeSH terms:
Contraceptive Agents
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Levonorgestrel
Contraceptives, Oral
Contraceptives, Oral, Combined
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Hemostatics
 Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Coagulants
Hematologic Agents
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on February 13, 2012



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