Double-blind trial investigating the efficacy of different doses of Progesterone compared with placebo for treatment of hot flashes

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 304

Inclusion Criteria

Subjects eligible for inclusion in the screening period of this study must satisfy all the following criteria:
1.Willing and able to provide written informed consent
2.Adult (= 18 years), postmenopausal women, where postmenopause is defined as
a.at least 12 months of spontaneous amenorrhea, or
b.6 months of spontaneous amenorrhea and follicle stimulating hormone (FSH) levels > 40 mIU/ml, or
c.status at least 6 weeks after bilateral oophorectomy with or without hysterectomy, or
d.subject post hysterectomy without oophorectomy with documented FSH level > 40 mIU/ml and estradiol level < 20 pg/ml
3.Non-smoker
4.Mammography without pathological findings obtained within routine medical care no longer than 12 months prior to screening visit
5.Cervical smear (Papanicolaou test) without pathological findings (i.e. < III) obtained no longer than 12 months prior to screening visit
In addition subjects need to fulfil the following criterion in order to be randomized (i.e. to enter the treatment period):
6.A minimum of 50 moderate to severe VMS episodes over the last 7 consecutive days prior to the baseline visit, as documented in the patient diary

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 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 64

Exclusion Criteria

1.Use of any hormone replacement therapy (including phytoestrogens and other plant-derived sex hormones) within 12 weeks prior to screening
2.Endometrial thickness = 5 mm at screening visit
3.Any history or current presence or suspicion of breast cancer, including carcinoma in situ and other pre-cancerous conditions
4.Active malignant disease of any organ system (except for localized basal cell carcinoma of the skin) or history thereof in the last 5 years prior to screening visit
5.Vaginal bleeding due to unidentified reason within 6 weeks prior to screening
6.Ongoing venous thromboembolic event or history thereof within 12 months prior to screening visit
7.Known severe renal insufficiency at screening visit
8.Known lipid metabolism disturbances of genetic origin (e.g. familial hypercholesterolemia, familial hypertriglyceridemia)
9.Acute or chronic liver diseases or a history of liver disease with liver enzymes having not normalized since then
10.Severe disturbances of hepatic function (including porphyria), hepatic tumors, also in medical history
11.Rotor syndrome or Dubin-Johnson syndrome
12.History of icterus or generalized pruritus during a previous pregnancy
13.History of myocardial infarction, stroke or transient ischemic attack or severe cardiac disease, including symptomatic chronic heart failure
14.Ongoing major depression
15.Use of SSRI, SNRI for any reason within 6 weeks prior to screening or planned use during the course of the study
16.Acupuncture for VMS within 2 weeks prior to screening or planned during the course of the study
17.Diabetes mellitus
18.Hypersensitivity to progesterone or excipients (e.g. soy) of the study medication
19.Medical history of HIV infection
20.Concomitant diseases or therapies that may cause VMS or affect VMS frequency or severity, e.g. but not limited to poorly controlled thyroid dysfunction (thyroid medication should be stable for at least 12 weeks prior to screening and TSH levels should be within range), fear disorders (e.g. panic disorders)
21.Participation in a clinical trial or intake of any investigational medicinal product within three months prior to screening visit
22.Previous participation in this clinical trial
23.Known or suspected drug or alcohol abuse.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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