Progestagen Type in Postmenopausal Hormone Therapy and Bl... | NCT01123538

Studies
Progestagen Type in Postmenopausal Hormone Therapy and Blood Gene Expression Profile

NCT01123538

Sponsor

University Hospital of North Norway

Status

Unknown status

Last Update Posted

Nov 3, 2011Estimated

Enrollment

40Estimated

Phase

Phase 4

Conditions

Pharmacogenomics
Systems Biology

Interventions

Progesterone
Chlormadinone acetate

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2006-004462-14	EudraCT Number

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Oct 2011Actual

Completion Date

Oct 2012Estimated

First Submitted Date

Apr 30, 2010

First Submission Date that Met QC Criteria

May 12, 2010

First Posted Date

May 14, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 2, 2011

Last Update Posted Date

Nov 3, 2011Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Natural progesterone	Other	Combined menopausal treatment containing natural progesterone	Drug: Progesterone
Chlormadinone acetate	Active Comparator	Combined menopausal treatment containing chlormadinone acetate	Drug: Chlormadinone acetate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Progesterone	Drug	200 mg/day oral micronized natural progesterone (e.g. Utrogestan® 100mg) + 0.05 mg/day transdermal (i.e. plaster) 17β-estradiol (e.g. Estraderm® 50µg) during a year

Measure	Description	Time Frame
Whole blood and white blood cells gene expression profiling after 3 months of HT treatment		0 and 3 months after treatment

Measure	Description	Time Frame
Quality of life, proteome, plasma haemostatic variable measurements		0,3,6 and 12 months
Whole blood and white blood cells gene expression profiling after 12 months of HT treatment		0 and 12 months after treatment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Postmenopausal women defined as:
- 45 years< age < 65 years
- Amenorrhoeic for ≥ 1 year
- Amenorrhoeic for < 1 year either without any withdrawal vaginal bleeding for 3 consecutive months in spite of a cyclic progestagen treatment and/or blood estradiol levels ≤ 20 pg/mL and blood FSH levels ≥ 40 UI/mL
- Women with bilateral ovariectomy
Women suffering of at least 1 postmenopausal symptoms listed:
- Hot flashes,
- Memory and Concentration Problems,
- Mood Swings,
- Insomnia,
- Urinary Incontinence,
- Night sweating,
- Join pains,
- Asthenia.
No use of hormone therapy (HT)
Previous HT user:
- HT use < 3 months - stop for 6 months
- HT use <= 1 year - stop for > 12 months
If previous use of soya derivatives in dietary supplements: washout period = 3 months
Signed informed consent, after having received both oral- and written- information regarding the study goals, its risks and benefits and its constraints, including the 12 month follow-up. A delay should be respected between information and the signature of the written consent.

Exclusion Criteria:

Past HT users who have used treatment for more than 1 year
Hysterectomized women
Women without health insurance (only in French centre)
History of cardio-vascular accident either arterial or venous
Untreated high blood pressure
Liver disease
Diabetes
History of cancer except basal-cell skin cancer and colon cancer
Severe history of familial breast cancer defined as at least 2 women first degree- relatives with breast cancer diagnosis before 50 years
History of severe mastalgia
History of breast biopsy showing hyperplasia (with or without atypia)
Undiagnosed vaginal bleeding
Diagnosed endometrial hyperplasia
Auto-immune disease (e.g. lupus)
Women with kidney transplant

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Eiliv Lund, MD, PhD	Institute of Community Medicine, Tromsø, Norway	Principal Investigator
Vanessa Dumeaux, PharmD, PhD	Institute of community medicine, Tromsø, Norway	Study Director

Type	Date	Date Unknown
Release	Nov 21, 2016
Reset	Jan 17, 2017

ID	Term
D011374	Progesterone
D002715	Chlormadinone Acetate

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473