Study for the assessment of clinical non-inferiority and tolerability of Estrogenon (Sanval Comercio e Industria Ltda) in comparasion to Premarin (Wyeth Industria Farmaceutica Ltda) in women post menopause.

Study for the assessment of clinical non-inferiority and tolerability of Estrogenon drug – conjugated estrogens, coated tablets coated tablet manufactured by Sanval Comercio e Industria Ltda. in comparison to (PREMARIN) coated tablets manufactured by Wyeth Industria Farmaceutica Ltda. in women post menopause

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000119099

Enrollment

Registered

2010-02-04

Start date

2010-03-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Patients at post-menopause phase, after signing Free and Informed Consent Term, shall pass through medical consultation and laboratorial exams (clinical analysis) including plasmatic dosing of Follicle-stimulating hormone (FSH), Luteinizing hormone (LH), Glutamate Oxaloacetate Transaminase (GOT) and glutamic-pyruvic transaminase (GPT), calcium and Total Estrogen (Estradiol) and Free Estrogen (Free Estriol), Glucose and total Cholesterol. A mammography will be performed in order to exclude patients with counter indication for the drug use. Patients shall be sent to undergo transvaginal ultrasound exam in order to assess their endometrium thickness. During medical consultation, vaginal walls as well as the cervix will be scraped for functional cytological and oncologic exam, using Papanicolaou test method. The procedures, in total or in part, shall be repeated at the following visits, within three months follow-up time period.

Interventions

Estrogen drug - conjugated estrogens, coated tablets 0,625mg/coated tablet manufactured by Sanval Comercio e Industria Ltda,taken orally once a day for a total of 90 days, in comparasion to Premarin 0,625 mg/coated tablet manufactured by Wyeth Industria Farmaceutica Ltda, taken orally once a day also for a total of 90 days.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Yes

Inclusion criteria

Women in menopause with indications for estrogen replacement therapy.

Exclusion criteria

Patients with contraindications for estrogen use.

Outcome results