Hormone Replacement TherapyPhase 4BrAVANCT00785317
Effects of Estradiol on Menopausal Breast
A Phase 4 study testing Angemin vs Activelle in people with Hormone Replacement Therapy, run by Karolinska Institutet at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 50 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hormone Replacement Therapy
- What is being tested?
- Angemin vs Activelle
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2008to Apr 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm
Eva Lundström
About this study
Official title: Effects of Oral 1 mg Oestradiol (E2)/ 2 mg of Drospirenone (DRSP) Compared to Oral 1 mg of Oestradiol (E2)/ 0.5 mg Noresthisterone Acetate (NETA)on the Postmenopausal Breast; a Double Blind Randomized Prospective Study
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.
- Conditions
- Hormone Replacement Therapy
- Being tested
- Angemin vs Activelle
- Keywords
- Postmenopausal Hormone Replacement Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angemin vs ActivelleDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Angemin | Experimental | 1 mg of oral oestradiol (E2) in continuous combination with 2 mg of DRSP Receives: Drug: Angemin vs Activelle |
| Activelle | Active comparator | 1 mg of oral E2 in continuous combination with 0.5 mg of NETA Receives: Drug: Angemin vs Activelle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mammographic breast density - classified according to digitized data-based quantification of breast density.
Measured: 6 months
Secondary outcomes (1)
Effects on serum levels of Oestradiol etc.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionOct 2009 (estimated)
- Study completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone Replacement TherapyStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00785317
- Sponsor's protocol ID
- 080818
- Acronym
- BrAVA
- Status last verified
- Nov 2008
- First submitted
- 4 Nov 2008
- Last updated
- 5 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral 1 mg Oestradiol (E2)/ 2 mg of Drospirenone (DRSP) Compared to Oral 1 mg of Oestradiol (E2)/ 0.5 mg Noresthisterone Acetate (NETA)on the Postmenopausal Breast; a Double Blind Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT00785317
- Acronym / sponsor ID
- BrAVA / 080818
- Conditions
- Hormone Replacement Therapy
- Keywords
- Postmenopausal Hormone Replacement Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 5 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Angemin | Experimental | Drug: Angemin vs Activelle1 mg of oral oestradiol (E2) in continuous combination with 2 mg of DRSP |
| Activelle | Active comparator | Drug: Angemin vs Activelle1 mg of oral E2 in continuous combination with 0.5 mg of NETA |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angemin vs Activelle1 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. | Drug | Activelle, Angemin |
Primary outcome
Mammographic breast density - classified according to digitized data-based quantification of breast density.
Time frame: 6 months
1 secondary outcome
Effects on serum levels of Oestradiol etc.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Angemin vs Activelle in people with Hormone Replacement Therapy, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eva Lundström (+46851770000, eva.lunstrom@karolinska.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mammographic breast density - classified according to digitized data-based quantification of breast density. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2008.