Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00785317
Other study ID # 080818
Secondary ID
Status Recruiting
Phase Phase 4
First received November 4, 2008
Last updated November 4, 2008
Start date November 2008
Est. completion date April 2010

Study information

Verified date November 2008
Source Karolinska Institutet
Contact Eva Lundström
Phone +46851770000
Email eva.lunstrom@karolinska.se
Is FDA regulated No
Health authority Sweden: The National Board of Health and Welfare
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effects on breast in postmenopausal women randomized to either oestradiol in combination with DRSP or E2 in combination with NETA during six months.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date April 2010
Est. primary completion date October 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 50 Years to 60 Years
Eligibility Inclusion Criteria:

- Naturally postmenopausal, symptomatic, apparently healthy women, with the need for hormone therapy aged 50 - 70 years with a BMI >18 and =30 kg/m2 and without any previous history of breast disease will be recruited for the study.

- They should be amenorrheic for at least 12 months or less than 12 months with S- FSH values >40 IU/L.

- They should be free of any sex hormone treatment for at least three months before inclusion.

Exclusion Criteria:

- General contraindications for HT according to Swedish product label. Age >60 years. BMI =18 or =30 kg/m2.

- Any previous history of cancer.

- Any previous history of breast disease or abnormal mammogram.

- In addition: hypertension (systolic BP >160 mm Hg or diastolic >100 mm Hg), hyperlipidemia (total cholesterol >8.0 mmol/L or triglycerides >3.0 mmol/L), diabetes mellitus, history of thromboembolic disease, heart failure, liver disease or porphyria, undiagnosed vaginal bleeding. No sex hormone treatment for at least three months before inclusion.

- No concomitant treatment known to influence hormone metabolism (warfarin, rifampicin, carbamazepine, griseofulvin, hydantoins, primidone, barbiturates, broad spectrum antibiotics) is to be accepted.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Angemin vs Activelle
1 mg of oral oestradiol (E2) in continuous combination with 2 mg of DRSP or 1 mg of oral E2 in continuous combination with 0.5 mg of NETA during six months.

Locations

Country Name City State
Sweden Karolinska University Hospital Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mammographic breast density - classified according to digitized data-based quantification of breast density. 6 months Yes
Secondary Effects on serum levels of Oestradiol etc. 6 months Yes
See also
  Status Clinical Trial Phase
Completed NCT04742816 - Renal Effects of Hormones/Biomarkers in Transgender PrEP Recipients Phase 4
Recruiting NCT04453332 - Effects of Hormone Replacement Therapy on Cardiovascular Risk and Body Composition Parameters N/A
Recruiting NCT06353555 - Efficacy of Thyroid Hormone Replacement for Secondary Hypothyroidism Following Intracerebral Hemorrhage N/A
Completed NCT04758871 - Oral Versus Vaginal Progesterone for Luteal Phase Supplementation in Frozen Embryo Transfer Cycles Phase 4
Not yet recruiting NCT04503915 - Estrogen Supplementation Mode in HRT-FET Cycle: a RCT N/A
Completed NCT00463450 - Efficacy of Gynodian® Depot in Women With Impaired Well-being Phase 3
Completed NCT00319072 - Hormone Replacement Therapy (HRT) Website Tool Phase 2
Recruiting NCT05166083 - Investigation of the Perceptual and Acoustic Voice in Trans Man
Completed NCT05774405 - Short-term Effects of Transdermal Estradiol on Female COVID-19 Patients Phase 2
Completed NCT01023802 - The Use of Molecular Breast Imaging in the Evaluation of Tumor Response to Neoadjuvant Therapy in Women With Breast Cancer N/A
Completed NCT01070979 - Hormone Replacement Therapy for Use in Postmenopausal Women for Relief of Hot Flushes and Urogenital Symptoms. Phase 3
Not yet recruiting NCT05122065 - Menopausal Vaginal Microbiome
Withdrawn NCT05168865 - Letrozole Versus Hormonal Preparation in Frozen Cycles of PCOS Patients. Phase 4
Completed NCT05072756 - Opinion of Brazilian Gynecologists on Hormone Therapy for Menopause and Prescriptive Habits
Recruiting NCT06372119 - Letrozole-stimulated Cycle Strategy Versus Artificial Cycle Strategy (LETSACT) N/A
Not yet recruiting NCT06357442 - Assessment of Endometrial Thickness Among Adolescent and Young Adult Patients on Estrogen Replacement Therapy Using Daily Oral Micronized Progesterone Versus the Etonogestrel Implant.
Recruiting NCT04478760 - Trans & Non-binary Reference Intervals While on Hormone Therapy Study
Completed NCT00012909 - Development and Evaluation of a Hormone Replacement Therapy Decision-Aid N/A