Klimadynon® in Comparison to Conjugated Oestrogens in Women Suffering From Menopausal Complaints

NCT02184364 | Completed Phase 3

• 1 other identifier: 563.1
• Study Type: interventional
• Target: 161
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate, relative to placebo and conjugated oestrogens, the efficacy, safety and tolerability of a 12 weeks peroral treatment twice daily with a cimicifuga racemosa extract corresponding to 20 mg, 75 mg or 150 mg plant material on menopause-related neurovegetative and mental complaints

Conditions

Menopause

Outcome Measures

Primary Outcomes (1)

• Change of score in menopause-related symptom categories of the modified menopausal rating scale (MRS)

  baseline, week 12

Secondary Outcomes (27)

• Change of score of MRS items 7-10 and items 1-10

  baseline, week 12

• Change of menopause index according to Kupperman

  Baseline up to day 98

• Changes in daily frequency of menopausal lead symptoms

  Up to day 105

• Changes from baseline in serum concentration of oestradiol-17ß

  Up to day 98

• Changes from baseline in serum concentration of FSH

  Up to day 98

Study Arms (5)

Low dose of Klimadynon®

EXPERIMENTAL

Drug: Low dose of Klimadynon®

Medium dose of Klimadynon®

EXPERIMENTAL

Drug: Medium dose of Klimadynon®

High dose of Klimadynon®

EXPERIMENTAL

Drug: High dose of Klimadynon®

Oestrofeminal®

ACTIVE COMPARATOR

Drug: Oestrofeminal®

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Low dose of Klimadynon® DRUG

Low dose of Klimadynon®

Medium dose of Klimadynon® DRUG

Medium dose of Klimadynon®

High dose of Klimadynon® DRUG

High dose of Klimadynon®

Oestrofeminal® DRUG

Oestrofeminal®

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Only postmenopausal (amenorrhea for 6 months at least) women may be enrolled in the study
• Women after ovariectomy may also be enrolled if surgery was carried out at least 6 months prior to the enrollment. Only women between the age of 40 and 60 may be included
• weeks (control -1, week -2, day -14) before the beginning of the treatment the following hormone values must have been analyzed:
• estradiol-17ß ≤ 0.15 nmol/l corresponding to ≤ 40 pg/ml and follicle stimulating hormone (FSH) ≥ 25 milliunits per milliliter (mU/ml)
• These hormone analyses must be carried out at the competent local laboratory
• In addition to other menopausal complaints the women must have hot flushes / outbreaks of sweating:
• Diary: During the "run-in period" daily ≥ 3 hot flushes / outbreaks of sweating
• Modified Menopause Rating Scale, 1st item twofold (week -2 and 0) ≥ 0.3
• A sum score taken twice from the modified (only items 1 - 6) Menopause Rating Scale within 2 weeks (week - 1 and 0) before the beginning of treatment must be ≥ 1.7
• In case of a pretreatment with estrogen a wash-out phase of 6 weeks is necessary in case of oral or transdermal administration. After the 4th week of wash-out the patient may be included in the "run-in period"

You may not qualify if:

• Non-responder (= no therapeutic success) under a pretreatment with estrogen
• Amenorrhea for \< 6 months
• In case of an estrogen pretreatment last menstruation (menopause) \> 3 years earlier
• Sum score of the modified Menopause Rating Scale (items 1 - 6) during the "run-in period" twice (week -2 and 0) \< 1.7
• At one of the appointments of the "run-in period" (week -2 and 0) more than one question of items 1 - 6 of the modified Menopause Rating Scale (MMRS) not answered
• During the "run-in period" at the appointment week -2: estradiol-17ß \> 40 pg/ml corresponding to \> 0.15 nmol/l and FSH \< 25 mU/ml
• Condition after hysterectomy
• Simultaneous ingestion of estrogen-containing products in addition to the test products
• Any addition ingestion of psychotropic drugs, antidepressants and sleeping aids (hypnotics / sedatives)
• Treatment with another study drug in the 2 months preceding the beginning of the study
• Considerable overweight (exceeding the target body weight \[height in cm minus 100\] by more than 30%)
• Poor general condition
• Alcohol or drug abuse
• Poor compliance
• Any contraindication for estrogen

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Klimadynon; Estrogens, Conjugated (USP)

Intervention Hierarchy (Ancestors)

Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2014
• First Posted: July 9, 2014
• Study Start: November 1, 1998
• Primary Completion: September 1, 2000
• Last Updated: July 14, 2014

Record last verified: 2014-07