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Bioidentical 'Natural' Hormone Evaluation in Early Menopause

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ClinicalTrials.gov Identifier: NCT00302731
Recruitment Status : Terminated
First Posted : March 14, 2006
Results First Posted : May 16, 2018
Last Update Posted : May 16, 2018
Sponsor:
Collaborators:
Private Foundation through KU Endowment
University of Kansas
Information provided by (Responsible Party):
Jeanne Drisko, MD, CNS, FACN, University of Kansas Medical Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Menopause
Interventions: Drug: Estradiol , estriol , progesterone
Drug: estradiol, progesterone
Drug: estriol, progesterone
Drug: equine estrogens m-progesteroneacetate

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Double blind single site pilot clinical trial conducted at academic medical center. Participants randomized to one of 4 arms by computer assignment conducted at independent site not enrolling subjects.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
If participants were on hormone replacement at enrollment, needed to have 3 month washout period before randomization. Participants were required to be nonsmokers, have intact uterus, and be menopausal. Screening ultrasound of the uterus, bone density, screening metabolic panel, and baseline mammogram were required.

Reporting Groups
  Description
Participants Randomized to Arm 1 Participants in Arm 1 received Prempro, premarin .45mg, provera 1.5mg conjugated estrogens, medroxyprogesterone acetate Prempro, premarin, provera conjugated estrogens, medroxyprogesterone acetate: Prempro, premarin .45mg, provera 1.5mg conjugated estrogens, medroxyprogesterone acetate
Participants Randomized to Arm 2

Participants in Arm 2 received compounded Estradiol .5mg, estriol 210mg, progesterone 100mg

Estradiol , estriol , progesterone: Estradiol .5mg, estriol 210mg, progesterone 100mg

Participants Randomized to Arm 3

Participants in Arm 3 received compounded estriol 2.5mg, progesterone 100mg

estriol, progesterone: estriol 2.5mg, progesterone 100mg

Participants Randomized to Arm 4

estradiol,progesterone

estradiol,progesterone: estradiol,progesterone


Participant Flow:   Overall Study
    Participants Randomized to Arm 1   Participants Randomized to Arm 2   Participants Randomized to Arm 3   Participants Randomized to Arm 4
STARTED   6   6   5   4 
COMPLETED   2   1   2   4 
NOT COMPLETED   4   5   3   0 
Lost to Follow-up                1                2                0                0 
Adverse Event                0                2                2                0 
Withdrawal by Subject                1                1                0                0 
Protocol Violation                1                0                0                0 
cancer unrelated to study discovered                1                0                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Study Arm 1

Prempro, premarin .45mg, provera 1.5mg conjugated estrogens, medroxyprogesterone acetate

Prempro, premarin, provera conjugated estrogens, medroxyprogesterone acetate: Prempro, premarin .45mg, provera 1.5mg conjugated estrogens, medroxyprogesterone acetate

Study Arm 2

Estradiol .5mg, estriol 210mg, progesterone 100mg

Estradiol , estriol , progesterone: Estradiol .5mg, estriol 210mg, progesterone 100mg

Study Arm 3

estriol 2.5mg, progesterone 100mg

estriol, progesterone: estriol 2.5mg, progesterone 100mg

Study Arm 4

estradiol,progesterone

estradiol,progesterone: estradiol,progesterone

Total Total of all reporting groups

Baseline Measures
   Study Arm 1   Study Arm 2   Study Arm 3   Study Arm 4   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   6   5   4   21 
Age 
[Units: Participants]
Count of Participants
         
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      6 100.0%      6 100.0%      5 100.0%      4 100.0%      21 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      6 100.0%      6 100.0%      5 100.0%      4 100.0%      21 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
         
United States   6   6   5   4   21 


  Outcome Measures

1.  Primary:   Change in Total Cholesterol   [ Time Frame: Baseline and month 12 ]

2.  Primary:   Endometrial Measurement   [ Time Frame: Baseline and month 12 ]

3.  Primary:   Number of Participants Without Change in Baseline and Follow up Mammograms   [ Time Frame: baseline and month 12 ]

4.  Secondary:   Number of Participants Without Change in Baseline and Follow up Bone Density   [ Time Frame: baseline and 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jeanne A Drisko, MD, CNS, FACN
Organization: University of Kansas Medical Center
phone: 913-588-6208
e-mail: jdrisko@kumc.edu



Responsible Party: Jeanne Drisko, MD, CNS, FACN, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00302731     History of Changes
Other Study ID Numbers: 9941
First Submitted: March 10, 2006
First Posted: March 14, 2006
Results First Submitted: April 27, 2017
Results First Posted: May 16, 2018
Last Update Posted: May 16, 2018