A multicenter, randomized, parallel-group, double-blind, placebo-controlled trial to evaluate the efficacy and safety of four different doses of Org 50081 in the treatment of moderate to severe vasomotor symptoms associated with the menopause - N/A

Phase 1

• Conditions: moderate to severe vasomotor symptoms associated with the menopause; MedDRA version: 7.0 Level: LLT Classification code 10020411

• Registration Number: EUCTR2004-000472-14-CZ
• Lead Sponsor: V Organon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-10-18
• Study Completion: 2006-01-15
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 900

Inclusion Criteria

1. postmenopausal women, defined as:
• 12 months of spontaneous amenorrhea; OR
• 6 months of spontaneous amenorrhea with serum FSH levels>40 mIU/mL; OR
• 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
In case the menopausal status of a subject is unclear because of a hysterectomy,
the serum FSH level must be >40 mIU/mL. If the date of the last menstruation is
not clear because of perimenopausal hormone use, then the subject must have a
serum FSH level >40 mIU/mL after completion of a washout period (see exclusion
criteria below).
2. age = 40 and = 65 years;
3. body mass index (BMI) = 18 and = 32 kg/m2;
4. minimum of 7 moderate to severe hot flushes per day or 50 per week, as
quantified from daily diary recordings during at least 7 days preceding
randomization to trial medication;
5. able to handle the electronic diary device after training and having at least 80%
compliance on complete daily diary entries during the period prior to randomization;
6. give voluntary written informed consent after the scope and nature of the
investigation have been explained, before screening evaluations.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

7. history or presence of any malignancy, except non-melanoma skin cancers;
8. any clinically unstable or uncontrolled renal, hepatic, endocrine, respiratory,
hematological, neurological, cardiovascular or cerebro-vascular disease that
would put the subject at safety risk or mask measure of efficacy;
9. history of seizures or epilepsy;
10. history or presence of clinically significant depression or other psychiatric
disorder which, in the opinion of the investigator, might compromise or confound
the subject’s participation in the trial;
11. abnormal, clinically relevant vaginal bleeding;
12. any clinically relevant (opinion of investigator) abnormal finding during physical,
gynecological and breast examination at screening;
13. abnormal, clinically relevant results of mammography. Mammography must have
been performed within the last 9 months prior to screening, otherwise it must be
done before inclusion into the trial. For non-US sites, if local laws or guidelines
do not allow or advise such frequent mammograms, the documented local laws
or guidelines should be followed;
14. abnormal cervical smear test results (corresponding to Pap III and higher,
including LSIL, HSIL, CIN 1 and higher). A cervical smear must have been performed within the last 9 months prior to screening, otherwise it must be done
before inclusion into the trial;
15. hematological or biochemical values at screening outside the reference ranges
considered clinically relevant in the opinion of the investigator;
16. high blood pressure (sitting systolic BP > 170 mmHg and/or diastolic BP > 100
mmHg);
17. use of any drug product containing estrogens, progestins, androgens or tibolone
prior to screening (and up to and including randomization) within:
• 1 week for prior vaginal hormonal products (rings, creams, gels)
• 4 weeks for prior transdermal products
• 8 weeks for prior oral products
• 8 weeks for intrauterine therapy
• 6 months for prior implant, pellet or injectable drug product;
18. any of the following treatments within the last 4 weeks prior to screening (and up to and including randomization):
• tricyclic antidepressants, SNRIs, SSRIs, MAO-inhibitors, mirtazapine
• antianxiety drugs, antipsychotics
• coumarin-derivatives
• a-adrenergic agents (e.g. clonidine, methyldopa)
• ß-blockers (e.g., propranolol)
• dopamine agonists/antagonists (e.g., veralipride, bromocriptine, domperidone)
• opiates, barbiturates
• raloxifene
• homeopathic menopausal preparations or other preparations intended to treat
climacteric or CNS symptoms (e.g. Black Cohosh, St. John’s Wort, isoflavone
supplements)
• hepatic microsomal enzyme-inducing drugs or drugs known to affect or
interfere with the pharmacokinetics of mirtazapine;
19. any condition or disease that could affect or int

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified