Women*s Hormonal Intervention Study in early Postmenopause of Estradiol-progesterone Replacement therapy - effects on quality of life

Phase 4

Withdrawn

• Conditions: Menopause; 10014701

• Registration Number: NL-OMON34966
• Lead Sponsor: Obstetrie & Gynaecologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

1. Postmenopausal women: last menstrual period between 6 months and maximum 2 years ago, FSH levels > 35 IU/L and estradiol levels < 20 picograms/mL (cut offs defined by central laboratory: *Klinisch Chemisch Laboratorium* at MUMC)
2. Endometrium thickness less than 5 mm
3. Negative progesterone challenge test
3. 4. Age between 45-55 years
5. Menopausal symptoms including at least moderate to severe vasomotor symptoms (defined as at least 35 moderate (sensation of heat with sweating, able to continue activity) to severe (sensation of heat with sweating, causing cessation of activity) hot flushes and/or night sweats per week
6. Intact uterus
7. Normal mammography within the last 12 months
8. Able to understand and sign informed consent form

Exclusion Criteria

1. Previous use of any hormone replacement therapy; except the use of estriol or phyto-estrogens
2. BMI > 35
3. Use of oral contraceptives during the last 2 months
4. Use of hormonal intra uterine device or implant during the last 2 months
5. Known contra-indications for Duogestan®:
- Known, past or suspected breast cancer;
- Known or suspected estrogen-dependent malignant tumours (e.g. endometrial cancer);
- Undiagnosed genital bleeding;
- Untreated endometrial hyperplasia;
- Previous idiopathic or current venous trhomboembolism (deep vein thrombosis, pulmonary embolism);
- Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction);
- Acute liver disease or a history of liver disease, until liver function tests have returned to normal;
- Known hypersensitivity to the active substances or to any of the excipients;
- Porphyria
6. Use of medication known to interact with 17 ß-estradiol or micronized progesterone;
- Substances known to induce drug-metabolising enzymes, particularly anticonvulsants (e.g. phenobarbital, phenytoin, carbamazepine) and anti-infectives (e.g. rifampicin, fifabutin, nevirapine, efavirenz)
- Ritonavir and nelfinavir
- Herbal preparations containing St. John*s Wort (Hypericum perforatum)
7. Participation in an investigational study within 30 days prior to administration of the study medication

Study & Design

• Study Type: Interventional
• Study Design: Not specified