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23 May 2012
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| [ Print-friendly version ] |
| Trial to evaluate the effect of low dose hormone therapy on menopausal symptoms and markers of bone turnover in postmenopausal women |
| ISRCTN | ISRCTN76005731 |
| ClinicalTrials.gov identifier | |
| Public title | Trial to evaluate the effect of low dose hormone therapy on menopausal symptoms and markers of bone turnover in postmenopausal women |
| Scientific title | A prospective, comparative, double-blind, parallel, multicenter, randomized, placebo-controlled trial to evaluate the effect of ultra-low dose hormone therapy (17beta-estradiol + norethisterone acetate) on climacteric symptoms and markers of bone turnover in postmenopausal women |
| Acronym | N/A |
| Serial number at source | LB1105 |
| Study hypothesis | This study aims to show the superiority of the ultra-low dose therapy compared to placebo in the treatment of climacteric symptoms. |
| Lay summary | Lay summary under review |
| Ethics approval | Ethics Committee, Faculty of Medicine of Jundiai, Brazil, 14 December 2011 |
| Study design | Randomized double-blind multicenter comparative prospective parallel placebo controlled trial |
| Countries of recruitment | Brazil |
| Disease/condition/study domain | Climateric symptoms |
| Participants - inclusion criteria |
1. Postmenopausal women aged 40 to 65 years
2. Intact uterus 3. Natural menopause, defined as (amenorrhea for at least 12 months and menopausal status must be confirmed by demonstrating levels of follicle stimulating hormone (FSH) > 30 mIU/mL and estradiol < 30 pg/ml) 4. Body mass index (BMI) between 19 and 35.0 kg/m2 5. A minimum average frequency of 50 moderate to severe hot flushes or night sweats episodes per week, as recorded by patient in the screening phase |
| Participants - exclusion criteria |
1. Known hypersensitivity to products containing estrogen and / or progestin
2. Surgical menopause 3. Endometrial thickness (bi-laminar) > 5 mm, measured by transvaginal ultrasound 4. Evidence of endometrial polyp by transvaginal ultrasound 5. Abnormal Pap smear, including cervical intraepithelial neoplasia (CIN) or cervical cancer 6. Prior exposure to hormone therapy with estrogen alone or combined therapy with estrogen / progestin, considering the following period before pre-selection (V0): 6.1 Vaginal therapy (cream, gel, vaginal capsule) - <4 weeks 6.2. Transdermal Therapy (gel, patch), nasal spray - <4 weeks 6.3. Estrogen therapy / estrogen-progestogen oral SERM (Raloxifene), Tibolone, Androgens - <8 weeks 6.4. Intra-uterine therapy (Mirena) - <8 weeks 6.5. Combined injectable therapy, progestin implant (Implanon) - <3 months 6.6. Estrogenic implant (Riselle) or progestin injection (Depo-Provera) - <6 months 7. Use of medications with known effects on vasomotor symptoms such as selective serotonin-norepinephrine reuptake inhibitor (SSRIs), clonidine, gabapentin, tibolone, methyldopa and phytoestrogens in the last 30 days 8. Use of medications with known effects on bone metabolism such as glucocorticoids, Gonadotropin-releasing hormone (GnRH) analogues, anticonvulsants, anticoagulants, immunosuppressive drugs, lithium, thyroxine, calcitonin and bisphosphonates within the last year 9. History or suspected uterine cancer, including endometrial hyperplasia and cancer 10. Abnormal genital bleeding unknown cause in the last 6 months 11. History or suspected breast cancer, ovarian cancer or estrogen-dependent neoplasia 12. Suspected mammography changes for breast cancer that require further investigation (simple cysts confirmed by breast ultrasound are be allowed) 13. History of conditions that affect bone metabolism, such as hypogonadism, gastrointestinal disturbances and hyperparathyroidism 14. History of diabetes mellitus (inclusion of patients with controlled diabetes - glycated hemoglobin <8% at screening ¨C is allowed) 15. History of thyroid disease with abnormal thyroid function (except for subclinical hypothyroidism) 16. History of hypertension with systolic blood pressure> 150 mmHg and / or diastolic pressure> 90 mm Hg (patients with hypertension controlled with antihypertensive drugs may be admitted in the study) 17. History of arterial or venous thromboembolic disease, including myocardial infarction, stroke, deep vein thrombosis and pulmonary embolism 18. History of hepatobiliary disease with hepatic enzymes elevation 19. Women smoking more than 20 cigarettes/day 20. History of alcohol or substance abuse 21. Any condition evaluated by medical history, physical examination or screening test (including but not limited to cardiovascular disease, neoplasias, complex ovarian disease, liver disease, kidney disease, blood disease, neurological or endocrine-metabolic disease) which as judged by the investigator, may be inappropriate for inclusion of patients in the study |
| Anticipated start date | 25/05/2012 |
| Anticipated end date | 30/03/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please contact Dr Andreia Neves, andreia.neves@libbs.com.br to request a patient information sheet |
| Target number of participants | 120 patients |
| Interventions |
Subjects will be randomized to receive either drug test or placebo for 24 weeks
1. Test drug = 17beta-estradiol (0.5 mg) + norethisterone acetate (0.1 mg) 2. Placebo Frequency of administration for both arms: 1 tablet, once a day during 24 weeks. The total period of follow up is 28 weeks for both arms. |
| Primary outcome measure(s) | Mean change from baseline to 24 weeks in frequency of hot flushes as recorded by patient in a daily diary |
| Secondary outcome measure(s) |
1. Changes in bone marker levels (P1NP, CTX-1, NTX and BSAP) from baseline to 12 and 24 weeks
2. Change in Vaginal Maturation Index (VMI) from baseline to 12 and 24 weeks 3. Mean change from baseline to 4, 8, 12 and 24 weeks in severity of hot flushes 4. Mean change from baseline to 4, 8 and 12 weeks in frequency of hot flushes 5. Quality of Life measured by Women's Health Questionnaire 6. Change in lab test results and clinical parameters |
| Sources of funding | Libbs Pharmaceutical Ltd (Brazil) |
| Trial website | |
| Publications | |
| Contact name | Dr Achilles Cruz |
| Address | Rua Josef Kryss, 250 |
| City/town | Sao Paulo |
| Zip/Postcode | 13209-000 |
| Country | Brazil |
| Sponsor | LIBBS Farmaceutica Ltd (Brazil) |
| Address |
Rua Josef Kryss
250 Barra Funda |
| City/town | São Paulo |
| Zip/Postcode | 01140-050 |
| Country | Brazil |
| Sponsor website: | http://www.libbs.com.br/home/ |
| Date applied | 06/12/2011 |
| Last edited | 11/01/2012 |
| Date ISRCTN assigned | 11/01/2012 |
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| © 2012 ISRCTN unless otherwise stated. | |
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