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This is a two-part study designed to evaluate the effect of Estetrol (E4) 15 or 20 mg, or placebo on the severity and frequency of vasomotor symptoms (VMS) (Efficacy Study Part) and the safety of E4 20 mg (Safety Study Part).
"This is a two-part study:
- The first part is the Efficacy Study mainly designed to evaluate the frequency and severity of vasomotor symptoms [VMS] in both hysterectomized and non hysterectomized postmenopausal participants after treatment with two doses of E4 (15 mg or 20 mg) or placebo for 12 consecutive weeks. Thereafter treatment will proceed for a total duration of 52 weeks, to continue the evaluation of secondary efficacy, safety and the effect on the endometrium. For endometrial protection, all non-hysterectomized subjects will receive treatment with 200 mg progesterone (P4) once daily for 14 consecutive days, after completion of the E4/placebo treatment.
- The second part is the Safety Study designed to evaluate the general safety, secondary efficacy (Lipid, glucose metabolism, health-related quality of life [HRQoL] and treatment satisfaction [TS]) after treatment with E4 20 mg for one year in hysterectomized postmenopausal participants."
Estetrol oral tablet, Placebo oral tablet
Not yet recruiting
Published on BioPortfolio: 2019-09-20T03:46:44-0400
This dose-finding study is being conducted to select the daily oral dose of estetrol (E4) for the treatment of vasomotor symptoms (VMS) in post-menopausal women.
The purpose of this trial was to evaluate the safety and tolerability of SPM 927 when given as iv infusions compared with oral administration of the same dose strengths in subjects who wer...
The bioavailability of the oral disintegrating tablet formulations given without water will be similar to an equivalent dose of the standard oral tablet given with water.
This is a phase IIa, double-blind, randomised, placebo-controlled, multi-center study to evaluate the effects of estetrol on testosterone suppression and quality of life in prostate cancer...
Estetrol (E4) is being developed in two indications supporting women health care: first E4 is combined with a progestin, [drospirenone (DRSP)] and is used as a new combined oral contracept...
Posaconazole is used to prevent invasive fungal infections (IFIs) in patients with hematologic malignancy. In this study, we compared plasma posaconazole concentrations (PPCs) and the incidence of bre...
As one of the new drugs of traditional Chinese medicine, Sanye Tablet is employed as a hypolipidemic in the traditional medicine, but the biopharmaceutical properties of the drug is still unclear.
Women with estrogen-sensitive cancer or survivors of these neoplasms are generally not candidates for systemic menopausal hormone therapy or tibolone for the treatment of bothersome vasomotor symptoms...
Corrigendum to Letter regarding Salma et al. "Vital signs changes during different dental procedures: A prospective longitudinal crossover clinical trial" Oral Surg Oral Med Oral Pathol Oral Radiol 128 (2019): 96.
Childhood maltreatment is related to adverse health outcomes. However, the relation of childhood maltreatment to the menopause transition-a universal transition for women often accompanied by troublin...
A branch of dentistry dealing with diseases of the oral and paraoral structures and the oral management of systemic diseases. (Hall, What is Oral Medicine, Anyway? Clinical Update: National Naval Dental Center, March 1991, p7-8)
The practice of personal hygiene of the mouth. It includes the maintenance of oral cleanliness, tissue tone, and general preservation of oral health.
Disorders of the mouth attendant upon non-oral disease or injury.
A dental specialty concerned with the diagnosis and surgical treatment of disease, injuries, and defects of the human oral and maxillofacial region.
An offensive, foul breath odor resulting from a variety of causes such as poor oral hygiene, dental or oral infections, or the ingestion of certain foods.