- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03749109
Quinagolide Vaginal Ring on Lesion Reduction Assessed by MRI in Women With Endometriosis/Adenomyosis (QLARITY)
A Randomised, Double-blind, Placebo-controlled, Proof-of-mechanism Phase 2 Trial Investigating the Effect of Quinagolide Extended-release Vaginal Ring on Reduction of Lesions Assessed by High-resolution Magnetic Resonance Imaging in Women With Endometrioma, Deep Infiltrating Endometriosis, and/or Adenomyosis
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Copenhagen, Denmark
- Gyneacology Rigshospitalet
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Berlin, Germany
- Charité Universitätsmedizin
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Dresden, Germany
- Universitätsklinikum Carl Gustav Carus
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Münster, Germany
- Universitatsklinikum Munster
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Florence, Italy
- Azienda Opsedaliera Universitaria Careggi
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Rome, Italy
- Università degli Studi di Roma La Sapienza
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Siena, Italy
- Azienda Ospedaliera Universitaria Senese
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Verona, Italy
- Azienda Ospedaliera Universitaria Integrata Verona
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Kraków, Poland
- Centrum Medyczne Promed
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Warsaw, Poland
- Gabinet Lekarski Specjalistyczny SONUS
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Warsaw, Poland
- Specjalistyczny Gabinet Lekarski
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pre-menopausal women between the ages 18-45 years (both inclusive) at the time of signing the informed consent
- Body mass index (BMI) of 18-35 kg/m2 (both inclusive) at screening
- Confirmation of deep infiltrating endometriosis (DIE), endometrioma or adenomyosis by high-resolution MRI at screening
- Transvaginal ultrasound (TVU) documenting a uterus with no abnormalities of endometrium and presence of at least one ovary with no clinically significant abnormalities at screening. Note that presence of uterine fibroids are not exclusionary but presence of any submucosal fibroids or polyps are exclusionary
- Willing and able to use a non-hormonal single-barrier method (i.e. condom) for contraception from the start of screening to the end-of-treatment. This is not required if adequate contraception is achieved by vasectomy of the male sexual partner, surgical sterilisation (e.g. tubal ligation and blockage methods such as ESSURE) of the subject, or true abstinence of the subject (sporadic sexual intercourse with men requiring condom use)
- Willing to avoid the use of vaginal douches or any other intravaginally administered medications or devices (except for tampons) from randomization to the end of treatment
Exclusion Criteria:
- Use of depot medroxyprogesterone acetate (MPA) within 10 months prior to the screening visit.
- Use of gonadotropin-releasing (GnRH) agonists (3-month depot) or dopamine agonists within 6 months prior to the screening visit.
- Use of GnRH agonists (1-month depot or nasal spray), GnRH antagonists, aromatase inhibitors, danazol, birth control implants (e.g. NEXPLANON), progestogen or levonorgestrel releasing intrauterine device (IUD) within 3 months prior to the screening visit.
- Use of hormonal contraceptives (including combined oral contraceptive pill, transdermal patch, and contraceptive ring) within 1 menstrual cycle prior to the screening visit.
- Contraindications to MRI such as having internal/external metallic devices and/or accessories (e.g. cardiac pacemakers and leg braces)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Quinagolide 1080 µg
Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.
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Vaginal ring containing Quinagolide 1080 µg for daily releases
Other Names:
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Placebo Comparator: Placebo
Vaginal ring containing matching placebo
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Matching placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Changes in the Sizes (mm) of Endometrioma, Deep Infiltrating Endometriosis (DIE) and Adenomyosis Lesions Summed by Type on Magnetic Resonance (MR) Images at Cycle 4
Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4. At screening, every measurable lesion (defined as ≥10 mm in size) of any type was recorded and was summed up by type for primary analysis. |
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Changes in the Sizes of Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4
Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.
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At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Proportion of Lesions by Type With a Decrease in a Size of ≥5 mm on MR Images at Cycle 4
Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.
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At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Proportion of Subjects With a Lesion of Any Type Decreased in a Size of ≥5 mm on MR Images at Cycle 4
Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.
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At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Number of New or Disappearing Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4
Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.
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At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Changes in the Volumes (mm3) of Endometrioma and DIE Lesions Summed by Type on MR Images at Cycle 4
Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.
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At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Changes in the Sizes of Endometrioma Assessed by Transvaginal Ultrasound (TVU) at Cycle 4
Time Frame: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
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Transvaginal ultrasound (TVU) will be performed, preferably by the same sonographer, at the screening visit and at end-of-treatment / cycle 4.
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At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
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Changes in the Mean Individual and Total Symptom and Sign Severity of Scores of the Biberoglu and Behrman (B&B) Scale at Cycle 4
Time Frame: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
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B&B scale is a used scale for endometriosis that consists of two parts, with the first part evaluating symptoms (i.e. different types of pain) and the second part evaluating physical signs. In the first part, the subject was asked to grade her pelvic pain (item A), dysmenorrhea (item B) and dyspareunia (item C) during the last menstrual cycle as none, mild, moderate or severe, corresponding to a score of 0-3. In the second part, the investigator graded the subject's pelvic tenderness (item D) and induration (item E) based on findings from a pelvic examination as none, mild, moderate or severe, corresponding to a score of 0-3. The total symptom and sign severity score was the sum of all five scores, i.e. A+B+C+D+E. The score can be between 0 and 15. |
At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
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Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4
Time Frame: At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)
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Assessed by Subjects. NRS is a 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Subjects were asked to score the worst pain in relation to endometriosis / adenomyosis on the NRS based on a recall of their experiences during the following timeframes:
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At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)
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Changes in the Endometriosis Health Profile-30 (EHP-30) Scores at Cycles 2 and 4
Time Frame: At baseline, at menstrual cycles 2 (~2 months) and 4 (~4 months)
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EHP-30 is a quality-of-life questionnaire. Score ranges from 0-100 and lower score denotes improvement. It consists of 30 questions measuring the frequency of the endometriosis impact on their quality of life during the past four weeks, with five options of never, rarely, sometimes, often and always. |
At baseline, at menstrual cycles 2 (~2 months) and 4 (~4 months)
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Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration)
Time Frame: At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)
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Assessed by subject self-reported answers to menstrual bleeding questions.
The Menstrual Cycle Duration is shown.
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At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)
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Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration)
Time Frame: At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)
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Assessed by subject self-reported answers to menstrual bleeding questions.
The Menstrual Bleeding Duration is shown.
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At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)
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Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4
Time Frame: Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months)
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Assessed by blood sample collection
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Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months)
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Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4
Time Frame: Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months)
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Assessed by blood sample collection
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Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months)
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Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4
Time Frame: Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months)
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Assessed by blood sample collection
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Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months)
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Plasma Concentrations of Quinagolide and Its Metabolites During Cycles 1 to 4
Time Frame: Within 1-5 days post randomization, within 7-14 days post randomization, and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)
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Assessed by blood sample collection
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Within 1-5 days post randomization, within 7-14 days post randomization, and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)
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Changes in Clinical Chemistry and Hematology Parameters: Hematocrit
Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Assessed by blood sample collection
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At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Changes in Clinical Chemistry and Hematology Parameters: Hemaglobin
Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Assessed by blood sample collection
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At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Hemoglobin
Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Assessed by blood sample collection
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At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular HGB Concentration
Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Assessed by blood sample collection
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At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Volume
Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Assessed by blood sample collection
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At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Changes in Clinical Chemistry and Hematology Parameters: Platelets
Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Assessed by blood sample collection
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At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Changes in Clinical Chemistry and Hematology Parameters: Erythrocytes
Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Assessed by blood sample collection
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At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Changes in Clinical Chemistry and Hematology Parameters: Leukocytes
Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Assessed by blood sample collection
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At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Changes in Clinical Chemistry and Hematology Parameters: Alanine Aminotransferase
Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Assessed by blood sample collection
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At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Changes in Clinical Chemistry and Hematology Parameters: Albumin
Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Assessed by blood sample collection
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At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Changes in Clinical Chemistry and Hematology Parameters: Alkaline Phosphatase
Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Assessed by blood sample collection
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At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Changes in Clinical Chemistry and Hematology Parameters: Aspartate Aminotransferase
Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Assessed by blood sample collection
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At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Changes in Clinical Chemistry and Hematology Parameters: Bicarbonate
Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Assessed by blood sample collection
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At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Changes in Clinical Chemistry and Hematology Parameters: Direct Bilirubin
Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Assessed by blood sample collection
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At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Changes in Clinical Chemistry and Hematology Parameters: Bilirubin
Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Assessed by blood sample collection
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At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Changes in Clinical Chemistry and Hematology Parameters: Calcium
Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Assessed by blood sample collection
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At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Changes in Clinical Chemistry and Hematology Parameters: Chloride
Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Assessed by blood sample collection
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At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Changes in Clinical Chemistry and Hematology Parameters: Cholesterol
Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Assessed by blood sample collection
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At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Changes in Clinical Chemistry and Hematology Parameters: Creatinine
Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Assessed by blood sample collection
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At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Changes in Clinical Chemistry and Hematology Parameters: Gamma Glutamyl Transferase
Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Assessed by blood sample collection
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At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Changes in Clinical Chemistry and Hematology Parameters: Glucose
Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Assessed by blood sample collection
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At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Changes in Clinical Chemistry and Hematology Parameters: Lactate Dehydrogenase
Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Assessed by blood sample collection
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At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Changes in Clinical Chemistry and Hematology Parameters: Phosphate
Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Assessed by blood sample collection
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At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Changes in Clinical Chemistry and Hematology Parameters: Potassium
Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Assessed by blood sample collection
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At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Changes in Clinical Chemistry and Hematology Parameters: Sodium
Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Assessed by blood sample collection
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At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Changes in Clinical Chemistry and Hematology Parameters: Protein
Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Assessed by blood sample collection
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At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Changes in Clinical Chemistry and Hematology Parameters: Urate
Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Assessed by blood sample collection
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At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Changes in Clinical Chemistry and Hematology Parameters: Urea Nitrogen
Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Assessed by blood sample collection
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At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Proportion of Subjects With Markedly Abnormal Changes in Clinical Chemistry and Hematology Parameters
Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Assessed by blood sample collection
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At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
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Frequency and Intensity of Adverse Events
Time Frame: From obtaining the informed consent to end of trial (up to 6 menstrual cycles ~ around 6 months, each cycle is approximately 28 days)
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Assessed by and Adverse Event Log completed by the Investigator
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From obtaining the informed consent to end of trial (up to 6 menstrual cycles ~ around 6 months, each cycle is approximately 28 days)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Global Clinical Compliance, Ferring Pharmaceuticals
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Uterine Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Endometriosis
- Adenomyosis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Dopamine Agonists
- Dopamine Agents
- Quinagolide
Other Study ID Numbers
- 000295
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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