A Trial in Healthy Female Subjects to Compare the Pharmacokinetics of Ethinyl Estradiol of NuvaRing®, a Contraceptive Patch (EVRA(TM)) and an Oral Contraceptive (Microgynon® 30) (Study 34237 (P06650)) (COMPLETED)

Sponsor
Organon and Co (Industry)
Overall Status
Completed
CT.gov ID
NCT01044056
Collaborator
(none)
24
3
3

Study Details

Study Description

Brief Summary

An open-label, randomized, parallel group trial in healthy female subjects to compare the pharmacokinetics of ethinyl estradiol (EE) of NuvaRing®, a contraceptive patch (EVRA(TM)) and an oral contraceptive (Microgynon® 30).

Condition or Disease Intervention/Treatment Phase
  • Drug: Levonorgestrel (LNG)/Ethinylestradiol (EE) oral contraceptive tablets
  • Drug: norelgestrominum and ethinylestradiol patch oral contraceptive patch
  • Drug: Nuvaring ™ (etonorgestrel/ethinylestradiol)
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
An Open-label, Randomized, Parallel Group Trial in Healthy Female Subjects to Compare the Pharmacokinetics of Ethinyl Estradiol of NuvaRing®, a Contraceptive Patch (EVRA(TM)) and an Oral Contraceptive (Microgynon® 30)
Study Start Date :
Mar 1, 2004
Actual Primary Completion Date :
Jun 1, 2004
Actual Study Completion Date :
Jun 1, 2004

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Levonorgestrel/ethinylestradiol oral contraceptive pill

Microgynon(R), 1 tablet every day for 21 days; each tablet contains 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE).

Drug: Levonorgestrel (LNG)/Ethinylestradiol (EE) oral contraceptive tablets
LNG/EE oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.
Other Names:
  • Microgynon
  • Batch Number: 374A 01K05
  • Active Comparator: Norelgestrominum and ethinylestradiol contraceptive patch

    Evra(TM), One patch applied on lower abdomen for 7 days for 3 consecutive weeks, 3 patches in total. Each patch contains 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.

    Drug: norelgestrominum and ethinylestradiol patch oral contraceptive patch
    A contraceptive patch (EVRA ™), one patch for 7 days for three consecutive weeks, 3 patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.
    Other Names:
  • EVRA ™
  • Batch number : 0311264
  • Active Comparator: Etonogestrel and ethinylestradiol contraceptive vaginal ring

    Nuvaring(R), Place the ring in the vagina for 21 days, remove for one week. Repeat with new Ring. Dose: per ring 11.7 mg ENG and 2.7 mg EE releasing a daily average amount of 0.120 mg ENG and 0.015 mg EE.

    Drug: Nuvaring ™ (etonorgestrel/ethinylestradiol)
    NuvaRing ™ , one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Concentration (Cmax) (Pharmacokinentic Parameter (PK)) for All Subjects in the Pharmacokinetically Evaluable (ASPE) Group [21 days of active treatment and washout period thereafter]

      Cmax was measured using ethinylstradiol serum concentration at several time points during the 21 days of active treatment and the washout thereafter.

    2. Area Under the Curve (AUC) 0-21 Days (PK Parameter) Measured for the ASPE Group [21 days]

      AUC 0-21 days was measured using ethinylestradiol serum concentration using a radio-immune assay at several time points during the 21 days of active treatment

    3. AUC 0-tlast (PK Parameter) for the ASPE Group. [21 days of active treatment and washout period thereafter]

      AUC 0-tlast was measured using ethinylestradiol serum concentrations using a radio-immune assay at several time points during the 21 days of active treatment and the washout period thereafter.

    4. AUC 0-infinity (PK Parameter) for the ASPE Group. [21 days of active treatment and the washout period thereafter]

      AUC 0-infinity was measured using ethinylestradiol serum concentration using a radio-immune assay at several time points during the 21 days of active treatment and the washout period thereafter. AUC 0-infinity was calculated as AUC 0-tlast extrapolated to infinity using the regression line from which t 1/2 was calculated.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Subject is at least 18 but not older than 40 years of age on Day 1 of treatment.

    • Subject has uterus and ovaria in situ

    • Subject who does not use hormonal contraception and is willing to use adequate nonhormonal contraceptive measures during the timeframe between screening and start treatment.

    • Subject is able and willing to refrain from caffeine and/or xanthine containing food and/or beverages (e.g. coffee, tea, cola or chocolate) from 24 hours before the first administration of the trial medication until the last PK blood sample.

    • Subject is willing not to consume grapefruit containing products 14 days prior to the start of the first administration of the trial medication until the last PK blood sample.

    • Subject is willing to refrain from smoking from 7 days prior to first administration of the trial medication until the last pharmacokinetic blood sample.

    • Subject is willing to refrain from alcohol containing products from 24 hours prior to first administration of the trial medication until the last pharmacokinetic blood sample.

    Exclusion Criteria:
    • Contraindications for use of NuvaRing, contraceptive patch and oral contraceptive:

    • Presence or history of venous thrombosis, with or without the involvement of pulmonary embolism.

    • Presence or history of arterial thrombosis (e.g. cerebrovascular accident, myocardial infarction) or prodromi of a thrombosis (e.g. angina pectoris or transient ischaemic attack).

    • Known predisposition for venous or arterial thrombosis, with or without hereditary involvement such as Activated Protein C (APC) resistance, antithrombin-III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinaemia, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant) and Factor V Leiden mutation.

    • Diabetes mellitus with vascular involvement

    • The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis (to be judged by the (sub-) investigator

    • Presence or history of severe hepatic disease as long as liver function values had not returned to normal or were judged to be clinically significant by the investigator.

    • Presence or history of liver tumours (benign or malignant).

    • Known or suspected malignant conditions of the genital organs or the breasts, if sex-steroid-influenced.

    • Undiagnosed vaginal bleeding.

    • Hypersensitivity to the active substances or to any of the excipients of NuvaRing, contraceptive patch and oral contraceptive.

    • Migraine with focal aura

    • Known or suspected pregnancy

    • Breastfeeding, or within 2 months after stopping breastfeeding on the day preceding the first administration of trial medication (Day -1).

    • Clinically significant abnormal laboratory, ECG (electrocardiogram) vital signs, physical and gynecological findings at screening.

    • A significant (history of) allergic or other serious disease, particularly gastrointestinal tract disease.

    • Smoking more than 5 cigarettes or 1 pipe or 1 cigar per day for a period of at least 3 months prior to screening.

    • Using any systemic medication (including over the counter (OTC) medication) during the 14 days prior to the day preceding the first administration of trial medication (Day -1), except for oral contraceptive used for synchronization and occasional Ibuprofen.

    • Used any drug or substance that is known to induce drug-metabolizing enzymes within two months prior to the start of synchronization.

    • Received a contraceptive by injection, an implant or hormonal intra-uterine device within 6 months of the day preceding the first administration of trial medication (Day -1), or a hormonal implant or hormonal intra-uterine device removed within 6 months of the day preceding the first administration of trial medication (Day -1).

    • Participated in a drug trial and was administered an investigational drug during the 90 days prior to start of synchronization.

    • Donated blood during the 90 days prior to the day preceding the first administration of trial medication (Day -1).

    • History (within the last 2 years) of excessive alcohol use, use of solvents or of drug abuse.

    • Positive drug test at screening and/or admission (Day -1), or a positive alcohol test at admission (Day -1).

    • Clinically significant abnormal cervical smear result (papaninecolaou (PAP) III or higher) at screening.

    • Acute or chronic hepatitis B/C or human immune deficiency virus (HIV) 1&2 infection.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Organon and Co

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Organon and Co
    ClinicalTrials.gov Identifier:
    NCT01044056
    Other Study ID Numbers:
    • P06650
    First Posted:
    Jan 7, 2010
    Last Update Posted:
    Feb 4, 2022
    Last Verified:
    Feb 1, 2022

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill Norelgestrominum and Ethinylestradiol Contraceptive Patch Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring
    Arm/Group Description Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days. A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day. NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.
    Period Title: Overall Study
    STARTED 8 8 8
    COMPLETED 8 8 8
    NOT COMPLETED 0 0 0

    Baseline Characteristics

    Arm/Group Title Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill Norelgestrominum and Ethinylestradiol Contraceptive Patch Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring Total
    Arm/Group Description Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days. A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day. NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE. Total of all reporting groups
    Overall Participants 8 8 8 24
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    25.6
    (5.44)
    24.8
    (6.59)
    23.1
    (3.64)
    24.5
    (5.24)
    Sex: Female, Male (Count of Participants)
    Female
    8
    100%
    8
    100%
    8
    100%
    24
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (participants) [Number]
    Netherlands
    8
    100%
    8
    100%
    8
    100%
    24
    100%

    Outcome Measures

    1. Primary Outcome
    Title Maximum Concentration (Cmax) (Pharmacokinentic Parameter (PK)) for All Subjects in the Pharmacokinetically Evaluable (ASPE) Group
    Description Cmax was measured using ethinylstradiol serum concentration at several time points during the 21 days of active treatment and the washout thereafter.
    Time Frame 21 days of active treatment and washout period thereafter

    Outcome Measure Data

    Analysis Population Description
    Subjects who received at least one dose of medication
    Arm/Group Title Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill Norelgestrominum and Ethinylestradiol Contraceptive Patch Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring
    Arm/Group Description Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days. A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day. NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.
    Measure Participants 8 6 8
    Mean (Standard Deviation) [pg/ml]
    168
    (29.5)
    105
    (12.4)
    37.1
    (5.1)
    2. Primary Outcome
    Title Area Under the Curve (AUC) 0-21 Days (PK Parameter) Measured for the ASPE Group
    Description AUC 0-21 days was measured using ethinylestradiol serum concentration using a radio-immune assay at several time points during the 21 days of active treatment
    Time Frame 21 days

    Outcome Measure Data

    Analysis Population Description
    Subjects who received at least one dose of medication.
    Arm/Group Title Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill Norelgestrominum and Ethinylestradiol Contraceptive Patch Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring
    Arm/Group Description Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days. A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day. NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.
    Measure Participants 8 6 8
    Mean (Standard Deviation) [nh.h/mL]
    21.9
    (2.9)
    35.8
    (5.5)
    10.6
    (2.5)
    3. Primary Outcome
    Title AUC 0-tlast (PK Parameter) for the ASPE Group.
    Description AUC 0-tlast was measured using ethinylestradiol serum concentrations using a radio-immune assay at several time points during the 21 days of active treatment and the washout period thereafter.
    Time Frame 21 days of active treatment and washout period thereafter

    Outcome Measure Data

    Analysis Population Description
    Subjects who received at least one dose of medication.
    Arm/Group Title Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill Norelgestrominum and Ethinylestradiol Contraceptive Patch Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring
    Arm/Group Description Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days. A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day. NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.
    Measure Participants 8 6 8
    Mean (Standard Deviation) [ng.h/mL]
    22.5
    (2.9)
    37.5
    (5.7)
    11.1
    (2.7)
    4. Primary Outcome
    Title AUC 0-infinity (PK Parameter) for the ASPE Group.
    Description AUC 0-infinity was measured using ethinylestradiol serum concentration using a radio-immune assay at several time points during the 21 days of active treatment and the washout period thereafter. AUC 0-infinity was calculated as AUC 0-tlast extrapolated to infinity using the regression line from which t 1/2 was calculated.
    Time Frame 21 days of active treatment and the washout period thereafter

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill Norelgestrominum and Ethinylestradiol Contraceptive Patch Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring
    Arm/Group Description Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days. A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day. NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.
    Measure Participants 8 6 8
    Mean (Standard Deviation) [ng.h/mL]
    22.7
    (2.8)
    37.7
    (5.6)
    11.2
    (2.7)

    Adverse Events

    Time Frame 21 days
    Adverse Event Reporting Description
    Arm/Group Title Levonorgestrel/Ethinylestradiol Oral Contraceptive Tablets Norelgestrominum and Ethinylestradiol Contraceptive Patch Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring
    Arm/Group Description Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon(R) 30), 21 in total, containing 0.150 mg LNG and 0.030 EE per tablet administered once daily orally for 21 consecutive days. A contraceptive patch (EVRA(TM), one patch for 7 days for three consecutive weeks, 3 patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgetromin and 0.750 mg EE releasing 0.150 mg norelegestromin and 0.020 mg EE per day. Nuvaring(R), one nring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonrgestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonorgestrel and 0.015 mg EE
    All Cause Mortality
    Levonorgestrel/Ethinylestradiol Oral Contraceptive Tablets Norelgestrominum and Ethinylestradiol Contraceptive Patch Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Levonorgestrel/Ethinylestradiol Oral Contraceptive Tablets Norelgestrominum and Ethinylestradiol Contraceptive Patch Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/8 (0%) 0/8 (0%) 0/8 (0%)
    Other (Not Including Serious) Adverse Events
    Levonorgestrel/Ethinylestradiol Oral Contraceptive Tablets Norelgestrominum and Ethinylestradiol Contraceptive Patch Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 5/8 (62.5%) 8/8 (100%) 8/8 (100%)
    Gastrointestinal disorders
    ABDOMINAL PAIN 0/8 (0%) 0 4/8 (50%) 6 1/8 (12.5%) 2
    DRY MOUTH 0/8 (0%) 0 0/8 (0%) 0 1/8 (12.5%) 1
    FLATULENCE 0/8 (0%) 0 1/8 (12.5%) 1 0/8 (0%) 0
    LOOSE STOOLS 0/8 (0%) 0 2/8 (25%) 2 0/8 (0%) 0
    NAUSEA 0/8 (0%) 0 3/8 (37.5%) 6 1/8 (12.5%) 1
    VOMITING 0/8 (0%) 0 1/8 (12.5%) 1 0/8 (0%) 0
    General disorders
    APPLICATION SITE DERMATITIS 0/8 (0%) 0 1/8 (12.5%) 1 0/8 (0%) 0
    APPLICATION SITE IRRITATION 0/8 (0%) 0 2/8 (25%) 2 0/8 (0%) 0
    APPLICATION SITE PRURITUS 0/8 (0%) 0 3/8 (37.5%) 4 0/8 (0%) 0
    FATIGUE 0/8 (0%) 0 3/8 (37.5%) 3 0/8 (0%) 0
    OEDEMA PERIPHERAL 0/8 (0%) 0 1/8 (12.5%) 1 0/8 (0%) 0
    VENIPUNCTURE SITE PAIN 1/8 (12.5%) 1 1/8 (12.5%) 1 0/8 (0%) 0
    Immune system disorders
    SEASONAL ALLERGY 1/8 (12.5%) 2 0/8 (0%) 0 1/8 (12.5%) 1
    Infections and infestations
    NASOPHARYNGITIS 0/8 (0%) 0 2/8 (25%) 2 2/8 (25%) 2
    UPPER RESPIRATORY TRACT INFECTION 0/8 (0%) 0 1/8 (12.5%) 1 0/8 (0%) 0
    Injury, poisoning and procedural complications
    ANIMAL SCRATCH 0/8 (0%) 0 1/8 (12.5%) 1 0/8 (0%) 0
    ARTHROPOD BITE 1/8 (12.5%) 1 0/8 (0%) 0 0/8 (0%) 0
    CONTUSION 0/8 (0%) 0 1/8 (12.5%) 1 0/8 (0%) 0
    FALL 0/8 (0%) 0 1/8 (12.5%) 1 0/8 (0%) 0
    MUSCLE STRAIN 0/8 (0%) 0 3/8 (37.5%) 3 0/8 (0%) 0
    SKIN LACERATION 0/8 (0%) 0 1/8 (12.5%) 1 0/8 (0%) 0
    Musculoskeletal and connective tissue disorders
    BACK PAIN 0/8 (0%) 0 1/8 (12.5%) 2 0/8 (0%) 0
    MYALGIA 0/8 (0%) 0 1/8 (12.5%) 1 1/8 (12.5%) 1
    Nervous system disorders
    DIZZINESS 0/8 (0%) 0 1/8 (12.5%) 2 0/8 (0%) 0
    HEADACHE 1/8 (12.5%) 1 5/8 (62.5%) 9 4/8 (50%) 10
    SYNCOPE VASOVAGAL 1/8 (12.5%) 1 0/8 (0%) 0 1/8 (12.5%) 1
    Psychiatric disorders
    MOOD ALTERED 0/8 (0%) 0 1/8 (12.5%) 1 0/8 (0%) 0
    Renal and urinary disorders
    DYSURIA 0/8 (0%) 0 1/8 (12.5%) 1 0/8 (0%) 0
    URINE ODOUR ABNORMAL 0/8 (0%) 0 0/8 (0%) 0 1/8 (12.5%) 1
    Reproductive system and breast disorders
    BREAST TENDERNESS 0/8 (0%) 0 5/8 (62.5%) 7 0/8 (0%) 0
    DYSMENORRHOEA 0/8 (0%) 0 2/8 (25%) 2 0/8 (0%) 0
    GENITAL PAIN 0/8 (0%) 0 1/8 (12.5%) 2 0/8 (0%) 0
    MENORRHAGIA 0/8 (0%) 0 1/8 (12.5%) 1 0/8 (0%) 0
    PELVIC PAIN 0/8 (0%) 0 0/8 (0%) 0 1/8 (12.5%) 1
    VAGINAL DISCHARGE 0/8 (0%) 0 0/8 (0%) 0 1/8 (12.5%) 1
    VAGINAL HAEMORRHAGE 0/8 (0%) 0 1/8 (12.5%) 4 1/8 (12.5%) 1
    Respiratory, thoracic and mediastinal disorders
    PHARYNGOLARYNGEAL PAIN 2/8 (25%) 2 1/8 (12.5%) 1 0/8 (0%) 0
    RHINORRHOEA 1/8 (12.5%) 1 0/8 (0%) 0 0/8 (0%) 0
    Skin and subcutaneous tissue disorders
    ACNE 0/8 (0%) 0 0/8 (0%) 0 1/8 (12.5%) 1
    ERYTHEMA NODOSUM 0/8 (0%) 0 1/8 (12.5%) 1 0/8 (0%) 0
    INGROWING NAIL 0/8 (0%) 0 1/8 (12.5%) 1 0/8 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT 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.

    Results Point of Contact

    Name/Title Senior Vice President, Global Clinical Development
    Organization Merck Sharp & Dohme Corp.
    Phone 1-800-672-6372
    Email ClinicalTrialsDisclosure@merck.com
    Responsible Party:
    Organon and Co
    ClinicalTrials.gov Identifier:
    NCT01044056
    Other Study ID Numbers:
    • P06650
    First Posted:
    Jan 7, 2010
    Last Update Posted:
    Feb 4, 2022
    Last Verified:
    Feb 1, 2022