Clinical Trials Logo
  1. Home
  2. Postmenopause
  3. NCT00913926
  4. Details
NCT00913926 Clinical Trial

Effects of Wellnara on Climacteric Symptoms

Postmenopause Clinical Trial

Official title:
Multicenter Non-interventional Study on Efficacy, Tolerability, and Acceptance of Wellnara Containing 1.03 mg Estradiol Hemihydrate (Equivalent to 1 mg Estradiol) and 0.04 mg Levonorgestrel for Treatment of Hormone Deficiency Symptoms in Postmenopausal Women During 6 Cycles of 28 Days.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00913926
Other study ID # 14575
Secondary ID WN0810DE
Status Completed
Phase N/A
First received June 3, 2009
Last updated April 21, 2015
Start date September 2007
Est. completion date May 2009

Study information
Verified date April 2015
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial Summary

Aim of this NIS is to obtain further information on efficacy, tolerability, and acceptance of Wellnara in a large user population under the conditions of routine medical practice. Furthermore, any adverse drug reactions will be recorded in a large user population under the conditions of medical routine. To investigate the efficacy of Wellnara, patients will fill in a questionnaire, the so-called Menopause Rating Scale (MRS II). Further, the effects of treatment on skin and hair will be evaluated by the investigator. Patients will assess treatment effects on their sexual life. Safety parameters include monitoring of vaginal bleeding, measurement of blood pressure and body weight, and - as far as routinely used in the practice - calculation of waist-hip-ratio. Any relevant additional information related to adverse drug reactions will also be documented.

Recruitment information / eligibility
Status Completed
Enrollment 749
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Women who have received a prescription of Wellnara on the basis of the decision of the treating gynecologist

Exclusion Criteria:

- Limited to the criteria listed in the expert information as contraindications

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• E2/LNG oral (Wellnara, BAY86-5029)
Patients in daily life treatment receiving Wellnara according to local drug information.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primary endpoint in the observation of efficacy concerning climacteric complaints is the change in Menopause Rating Scale (MRS II) in relation to the status immediately before starting treatment (Baseline). At Baseline, after 3 months, after 6 months No
Secondary Effects on climacteric-related skin, hair, and sexual problems At Baseline, after 3 months, after 6 months No
Secondary Subjective assessment of efficacy After end of study No
Secondary Body weight At Baseline, after 3 months, after 6 months Yes
Secondary Blood Pressure At baseline, end of Study Yes
Secondary Waist-hip-ratio (as far as routinely used in the practice) At baseline, after 6 months Yes
Secondary Occurrence of vaginal bleeding After 3 months, after 6 months Yes
Secondary Subjective assessment of tolerability End of study Yes
Secondary Adverse drug reactions During the whole study Yes
See also
  Status Clinical Trial Phase
Completed NCT05448079 - The Effect of Sexual Counseling Given According to the PLISSIT Model on FSFI, MAS and SQOL-F of Postmenopausal Women N/A
Completed NCT00745173 - Study Evaluating Premarin and Bazedoxifene Potential Interaction Phase 1
Completed NCT00550433 - Study Evaluating Bazedoxifene/CE in Postmenopausal Women Phase 1
Completed NCT00515593 - PROPOSE Quality - PReOtact in Postmenopausal OStEoporosis - Quality of Life Study (FP-004-DE) N/A
Completed NCT00381251 - Study Comparing Bioequivalence of Two New Formulations of Premarin/MPA With Premarin/MPA Reference Formulation. Phase 1
Completed NCT00185328 - Efficacy and Tolerability of Angeliq in Thai Women Phase 4
Completed NCT00484107 - Tolerability & Safety of Premarin Vaginal Cream in Indian Postmenopausal Women Phase 4
Completed NCT00023543 - Reduction of Triglycerides in Women on Hormone Replacement Therapy Phase 2
Completed NCT00152282 - A Study to Evaluate the Safety and Effectiveness of Asoprisnil and Estrogen Administration to Postmenopausal Women Phase 2
Completed NCT00006407 - Sex Steroid Hormones and Risk of CHD in Women N/A
Completed NCT00006539 - Thrombotic, Inflammatory & Gene Markers of CVD in Women N/A
Completed NCT00010712 - Effects of Black Cohosh on Menopausal Hot Flashes Phase 2
Completed NCT00001752 - Vascular and Metabolic Effects of Hormone Therapy Combined With L-Arginine in Postmenopausal Women Phase 2
Completed NCT00005515 - Mutations, Hormone Therapy (HRT) and Venous Thromboembolism N/A
Completed NCT00000481 - Women's Health Trial: Feasibility Study in Minority Populations Phase 3
Completed NCT00000466 - Postmenopausal Estrogen/Progestin Interventions (PEPI) Phase 3
Completed NCT00543634 - Study Comparing Premarin®/MPA, PREMPRO® and Provera® in Healthy Postmenopausal Women Phase 1
Completed NCT06115577 - Endometrial Tissues and Mononuclear Cells Receptivity in Pathogenesis of Endometrial Proliferative Processes
Completed NCT01556737 - Effect of Two Different Isoflavone Supplement Preparations on Gene-expression in Postmenopausal Women N/A
Completed NCT00455741 - Postmenopausal Women Estrogen and Progesterone Infusion Phase 1/Phase 2

External Links