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Comparative effects of 2 types of hormone replacement therapy on climacteric symptoms

Comparative effects of conventional hormone replacement therapy and tibolone on climacteric symptoms and sexual dysfunction in postmenopausal women

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT138809032766N1
Enrollment
150
Registered
2010-04-26
Start date
2006-12-22
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

menopause. Menopausal and female climacteric states

Interventions

Intervention 1: group A: Continuous conjugated estrogen (CE) 0.625mg plus medroxyprogestrone acetate (MPA) 2.5mg. Intervention 2: group B: Tibolone 2.5mg/day. Intervention 3: group C (placebo group):C
Treatment - Drugs
Placebo
group A: Continuous conjugated estrogen (CE) 0.625mg plus medroxyprogestrone acetate (MPA) 2.5mg
group B: Tibolone 2.5mg/day
group C (placebo group):Ca-D (500 mg +200 IU)

Sponsors

Tarbiat Maodares University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
45 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: married, menopause after 40 years old and 12 months amenorrhea or 6 month amenorrhea and serum Estradiol less than 50 pg/dl. Exclusion criteria: any history of active hepatitis, cardiovascular, inflamation disease (infectious or uninfectious), thoromboambolic or cerebrovascular disorder, psychosis, hyperlipidemia, history of chemotherapy or radiation, HRT treatment in previous 6 months, use of vitamine E, fluxitine, soymenopause,propranolol and another herbal or chemical druge, smoking, alchol or addiction

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Climacteric symptom. Timepoint: 6 month. Method of measurement: Greene Climacteric Scale & Female Sexual Function Index.

Secondary

MeasureTime frame
Sex hormone status & sex hormone-binding globulin (SHBG). Timepoint: 6 month. Method of measurement: biochemistry.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSedigheh Moghasemi

Golestan University of Medical Sciences

moghasemi.s@gmail.com & nasim_908@yahoo.com+98 17 1443 0351

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026