TRANSDERMAL HRT RELIEVING POSTMENOPAUSAL SYMPTOMS (THRT)

• ClinicalTrials.gov Identifier: NCT02033512
• Recruitment Status: Completed
• First Posted: January 10, 2014
• Last Update Posted: January 10, 2014
• Sponsor: University Potiguar
• Collaborator: Universidade Federal de Sergipe
• Information provided by (Responsible Party): MARCO BOTELHO, University Potiguar

Tracking Information

• First Submitted Date: December 10, 2013
• First Posted Date: January 10, 2014
• Last Update Posted Date: January 10, 2014
• Study Start Date: January 2003
• Actual Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 9, 2014)

Estradiol Levels [ Time Frame: 5 years ]

Effect of Progesterone (10%) associated with Estriol (0.1) +Estradiol (0.25%) Nanoparticles formulation on Estradiol serum levels The serum levels of estradiol, over the 60 months of THRT are shown in Figure 8. Statistical analysis of mean Estradiol pretreatment values at baseline was 28.88 ± 39.62 (pg/mL) and after 60 months of THRT showed a significant increase to 51.85 ± 77.50. The data reached a statistical difference (p<0.05) after the treatment with the transdermal formulation.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: January 9, 2014)

Effect of Progesterone (10%) associated with Estriol (0.1) +Estradiol (0.25%) Nanoparticles formulation on postmenopausal complaints [ Time Frame: 5 years ]

The postmenopausal symptomatology analysis of the volunteers subjected to THRT that received the nanoformulation revealed a significant decreasing of postmenopausal scores complaints (Figure 3). These values were statistically significant (P < 0.05), when the mean values from baseline were compared after 60 months of treatment. The extent of satisfaction with the hormone therapy was ~75%. The continuation induced further increases in the extent of satisfaction: 85.2 after one year and 92.5 ± 4.2% at the end of study (P < 0.05).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: TRANSDERMAL HRT RELIEVING POSTMENOPAUSAL SYMPTOMS
• Official Title: NANOSTRUCTURED TRANSDERMAL HORMONE REPLACEMENT THERAPY RELIEVING MENOPAUSAL SYMPTOMS: A CONFOCAL RAMAN SPECTROSCOPY STUDY
• Brief Summary: There is a dilemma and a permanent debate about side effects on drugs administered orally. The first-pass metabolism is related with many side effects, since the metabolites of these compounds affect the course of human physiology. Conventional hormone therapy by oral route has been used for relieving menopausal symptoms. Transdermal estrogens have not been used extensively in Brazilian women with menopausal symptomatology, however; recently a previous long term study has indicated no increased risk breast cancer or vasomotor disorders in menopausal women, using transdermal HRT.

Detailed Description

This was a prospective long-term clinical trial study of female patients aged 51-70 years old treated for menopause related hormone imbalances. Other results of this study are published elsewhere. Volunteers were recruited from referenced Gynecological Medical service where patient charts are maintained.

This study is a prospective long-term clinical trial study randomized trial assessing the effects of Transdermal HRT on climacteric symptoms and hormone serum levels in early postmenopausal women. Preliminary results of this trial, including the first 42 women enrolled, have been published (3).

In the present analysis, 66 women received daily in the right and left forearms a transdermal nanostructured formulation of Estriol (0.1%) + Estradiol (0.25%) and Progesterone (10%) respectively (Biolipid B2®, Evidence, SP, Brazil) for sixty months. The following were compared: effects of transdermal gel on baseline and after THRT were also analyzed.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Menopause

Intervention

• Drug: Transdermal Hormone Replacement Therapy

  The Blood samples were collected from the subjects early in the morning after an overnight fast. After serum testing, the identification hormone deficiencies, was determined and then, if necessary, additional transdermal progesterone was prescribed. The patients were evaluated 3 months after THRT treatment protocol.

  All the patients were instructed about how to use the progesterone pump for transdermal application, performed in the presence of an experienced physician, in order to guarantee standardization and correct use of the THRT. Compliance was defined as completing seventy percent or more of the transdermal applications.

  Other Name: Biolipideo/B2®
• Drug: Transdermal Nanoformulation
  The Blood samples were collected from the subjects early in the morning after an overnight fast. After serum testing, the identification hormone deficiencies, was determined and then, if necessary, additional transdermal hormones were prescribed.
  Other Name: Biolipid/B2, Biolipideo/B2, Evidence Soluções Farmaêuticas
• Drug: Transdermal formulation
  66 patients completed the study. In the present analysis, the subjects received daily in the right and left forearm a transdermal nanostructured formulation of Estriol (0.1%) + Estradiol (0.25%) and Progesterone (10%) respectively (Biolipid B2®, Evidence, SP, Brazil) for sixty months. The effects of transdermal hormone formulation were analyzed.
  Other Name: Biolipid/B2®

• Study Arms: Not Provided
• Publications *: Botelho MA, Queiroz DB, Barros G, Guerreiro S, Fechine P, Umbelino S, Lyra A, Borges B, Freitas A, Queiroz DC, Ruela R, Almeida JG, Quintans L Jr. Nanostructured transdermal hormone replacement therapy for relieving menopausal symptoms: a confocal Raman spectroscopy study. Clinics (Sao Paulo). 2014 Feb;69(2):75-82. doi: 10.6061/clinics/2014(02)01.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 9, 2014): 66
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: April 2008
• Actual Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 1) last menstrual period between 6 months and 3 years before the beginning of the study plus follicle-stimulating hormone (FSH) levels higher than 35 IU/L; 2) age between 51 and 70 years; 3) no use of any medication known to interfere with hormonal levels in the past 6 months.

Exclusion Criteria:

• Patients presenting diabetes, previous hysterectomy, endometrial thickness higher than 5 mm, history of cancer, thromboembolism or established cardio vascular disease were excluded.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 51 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT02033512
• Other Study ID Numbers: CNPQ202316; CNPq ( Other Grant/Funding Number: CNPq202316/2001-4 )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: MARCO BOTELHO, University Potiguar
• Study Sponsor: University Potiguar
• Collaborators: Universidade Federal de Sergipe

Investigators

• Principal Investigator: MARCO A BOTELHO, PhD; University Potiguar
• Study Chair: Dinalva B Queiroz, MsC; School of Health

• PRS Account: University Potiguar
• Verification Date: January 2014