MenopausePhase 1HRTNCT00864214

A Pharmacokinetic Evaluation of Bioidentical Compounded Estrogen Cream and Natural Progesterone

A Phase 1 study testing bioidentical hormone (Biest) and bioidentical hormone (Vivelle-Dot) in people with Menopause, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for: Menopause
What is being tested?: bioidentical hormone (Biest) and bioidentical hormone (Vivelle-Dot)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: Jun 2008to Apr 2010
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 60 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Women 40-60 years old;
Postmenopausal status, as documented by absence of periods for ≥ 1 year or amenorrhea for ≥ 6 months along with FSH ≥ 40 IU/L;
Surgical menopause;
History of a normal mammogram within the last 11 months;
Normal screening labs (within 20% of upper limit of lab normal);
Able to understand and sign informed consent; and
Able and willing to be in a monitored CRU setting and provide blood samples as requested.

Who cannot join

Contraindications to the use of hormones because of personal history of coronary artery disease, stroke, breast cancer, DVT/PE, active liver or gall bladder disease, hormone dependent migraine headaches, endometrial, ovarian or other hormone dependent cancers;
Medical conditions increasing the risk of complications from hormone replacement such as uncontrolled hypertension (>160/100 mmHg), smoking, diabetes and lupus;
Current use of estrogen, progesterone or testosterone;Depending on the drug, it could be 7 days to 6 months.
Current use of isoflavone containing products;
Current use of protein binding medications like rifampin, warfarin, antiepileptic drugs (effect on estrogen bioavailability);
Family history of premenopausal breast cancer in a first degree relative, two or more premenopausal breast cancers in second degree relatives, male breast cancer, ovarian cancer in two or more relatives and; and

Show all 10Show fewer

Women with alcohol or substance abuse or dementia (compliance issues).
Women who are more than ten years from their last menstrual period (unfavorable risk : benefit ratio)
Women with peanut allergy (Prometrium has peanut oil)
Women who are found to have premenopausal estrogen levels, as confirmed by a baseline Estradiol level of >35 pg/ml and vaginal ultrasound suggesting ovarian activity.

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic
Rochester, Minnesota, 55905

Other trials in United States

About this study

Bioidentical compounded hormone therapy (BCHT) is considered a 'safer' option to the conventional hormones (HT) by its proponents. However, there is limited research data to support their claims. Our group at the Women's Health Clinic, in collaboration with the Departments of Endocrinology, Complementary Medicine and Laboratory Medicine, is interested in developing a line of research to test the safety and efficacy of BCHT. In the present study, we aim to find the dose of BCHT that is bioequivalent to conventional HT, in a randomized, blinded, four-arm, phase I clinical trial. We will estimate the levels of estrone (E1), estradiol (E2) and estriol (E3) at baseline and at steady state with two-weeks of administration of three commonly used doses of bioidentical compounded estrogen cream (Biest) and a standard dose conventional estrogen patch (Vivelle-Dot). E1, E2, and E3 values will be summarized using point estimates and 95% confidence intervals. Two-sample t-test will be used to compare each Biest group to the Vivelle-Dot group. Healthy postmenopausal women, with no contraindications for hormone use, who are able to fully understand and participate in the trial, will be enrolled. We will utilize the resources of Mayo CRU to conduct this study.

Read the detailed description

This study is designed as a Phase I, blinded, randomized, four-arm clinical trial. Participants will be randomized to one of the four interventions: Biest transdermal cream 2.0 mg/0.5 g daily, Biest 2.5 mg/0.5 g daily, Biest 3.0 mg/0.5 g daily or Vivelle-Dot patch 0.05 mg/24 hours changed biweekly. Serum levels of E1, E2, E3 and progesterone will be obtained at baseline before starting the intervention and then multiple times on days 1 15 and 16 of study, as outlined in the table below (Table 3.1). The peak and steady state concentrations of E1, E2 and E3, along with time to reach the peak levels, and area under the curve will be calculated. Baseline and steady state levels of progesterone will also be compared between the compounded and micronized progesterone groups. If there are abnormalities in estrogen levels or symptoms suggesting such, a vaginal ultrasound would be done to exclude possible ovarian activity as a source.

Conditions: Menopause
Being tested: bioidentical hormone (Biest), bioidentical hormone (Vivelle-Dot)
Keywords: bioidentical hormone, menopause, estrogen, progesterone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

bioidentical hormone (Biest)Drug
Estrogen is the Biest 2.0 mg bioidentical cream; the placebo is the transdermal patch; the progesterone is compounded progesterone-100 mg
bioidentical hormone (Biest)Drug
Estrogen is the Biest 2.5 mg bioidentical cream; the placebo is the transdermal patch; the progesterone is compounded progesterone-100 mg
bioidentical hormone (Biest)Drug
Estrogen is the Biest 3.0 mg bioidentical cream; the placebo is the transdermal patch; the progesterone is compounded progesterone-100 mg
bioidentical hormone (Vivelle-Dot)Drug
Estrogen is the Vivelle-Dot patch 0.05 mg; the placebo is the transdermal cream; the progesterone is micronized progesterone-100 mg

Study groups in NCT00864214
Study group	Role	What they receive
1	Experimental	Estrogen is the Biest 2.0 mg bioidentical cream; the placebo is the transdermal patch; the progesterone is compounded progesterone-100 mg Receives: Drug: bioidentical hormone (Biest)
2	Experimental	Estrogen is the Biest 2.5 mg bioidentical cream; the placebo is the transdermal patch; the progesterone is compounded progesterone-100 mg Receives: Drug: bioidentical hormone (Biest)
3	Experimental	Estrogen is the Biest 3.0 mg bioidentical cream; the placebo is the transdermal patch; the progesterone is compounded progesterone-100 mg Receives: Drug: bioidentical hormone (Biest)
4	Experimental	Estrogen is the Vivelle-Dot patch 0.05 mg; the placebo is the transdermal cream; the progesterone is micronized progesterone-100 mg Receives: Drug: bioidentical hormone (Vivelle-Dot)

What is being measured

The primary outcome is the main question the study is designed to answer.

To measure estrone, estradiol and estriol levels at baseline and after achieving a steady state with 15-days of administration of three commonly used doses of bioidentical compounded estrogen cream and a standard dose conventional estrogen patch.
Measured: Day 1 and Day 15
To measure the progesterone levels at baseline and after achieving a steady state with 15-days of administration of 100 mg/day of two different oral progesterone formulations.
Measured: Day 1 and Day 15

Secondary outcomes (3)

To assess the feasibility of conducting a clinical trial randomizing patients to daily estradiol-estriol transdermal cream or biweekly estradiol patch for 15 days in 40 healthy postmenopausal women.
Measured: Day 1 and Day 15
To assess the tolerability of use of daily estradiol-estriol transdermal cream and biweekly estradiol patch for 15 days in 40 healthy postmenopausal women in a randomized clinical trial.
Measured: Day 1 and Day 15
To test if genetic variation in SULT1A1 copy number and single nucleotide polymorphisms (SNPs) influences estrogen pharmacokinetics in 40 healthy postmenopausal women receiving exogenous estrogen therapy.
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2008Apr 2010

First posted18 Mar 2009 (estimated)
Study startJun 2008
Primary completionDec 2009
Study completionApr 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for MenopauseStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00864214
Sponsor's protocol ID: 06-006363
Other IDs: 08-000223
Acronym: HRT
Status last verified: Jan 2012
First submitted: 17 Mar 2009
Last updated: 16 Jan 2012
Results posted: No
Data monitoring committee: Yes

Publications

Sood R, Warndahl RA, Schroeder DR, Singh RJ, Rhodes DJ, Wahner-Roedler D, Bahn RS, Shuster LT. Bioidentical compounded hormones: a pharmacokinetic evaluation in a randomized clinical trial. Maturitas. 2013 Apr;74(4):375-82. doi: 10.1016/j.maturitas.2013.01.010. Epub 2013 Feb 4.
PubMed 23384975

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pharmacokinetic Evaluation of Bioidentical Compounded Estrogen Cream and Natural Progesterone
ClinicalTrials.gov ID: NCT00864214
Acronym / sponsor ID: HRT / 06-006363
Conditions: Menopause
Keywords: bioidentical hormone, menopause, estrogen, progesterone
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: Jun 2008
Primary completion: Dec 2009 (actual)
Study completion: Apr 2010 (actual)
First posted: 18 Mar 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
1	Experimental	Drug: bioidentical hormone (Biest)Estrogen is the Biest 2.0 mg bioidentical cream; the placebo is the transdermal patch; the progesterone is compounded progesterone-100 mg
2	Experimental	Drug: bioidentical hormone (Biest)Estrogen is the Biest 2.5 mg bioidentical cream; the placebo is the transdermal patch; the progesterone is compounded progesterone-100 mg
3	Experimental	Drug: bioidentical hormone (Biest)Estrogen is the Biest 3.0 mg bioidentical cream; the placebo is the transdermal patch; the progesterone is compounded progesterone-100 mg
4	Experimental	Drug: bioidentical hormone (Vivelle-Dot)Estrogen is the Vivelle-Dot patch 0.05 mg; the placebo is the transdermal cream; the progesterone is micronized progesterone-100 mg

Who may qualify

Ages: 40 to 60 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Women 40-60 years old;
Postmenopausal status, as documented by absence of periods for ≥ 1 year or amenorrhea for ≥ 6 months along with FSH ≥ 40 IU/L;
Surgical menopause;
History of a normal mammogram within the last 11 months;
Normal screening labs (within 20% of upper limit of lab normal);

Key exclusion criteria (10 listed)

Contraindications to the use of hormones because of personal history of coronary artery disease, stroke, breast cancer, DVT/PE, active liver or gall bladder disease, hormone dependent migraine headaches, endometrial, ovarian or other hormone dependent cancers;
Medical conditions increasing the risk of complications from hormone replacement such as uncontrolled hypertension (>160/100 mmHg), smoking, diabetes and lupus;
Current use of estrogen, progesterone or testosterone;Depending on the drug, it could be 7 days to 6 months.
Current use of isoflavone containing products;
Current use of protein binding medications like rifampin, warfarin, antiepileptic drugs (effect on estrogen bioavailability);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
bioidentical hormone (Biest)Estrogen is the Biest 2.0 mg bioidentical cream; the placebo is the transdermal patch; the progesterone is compounded progesterone-100 mg	Drug	1
bioidentical hormone (Biest)Estrogen is the Biest 2.5 mg bioidentical cream; the placebo is the transdermal patch; the progesterone is compounded progesterone-100 mg	Drug	2
bioidentical hormone (Biest)Estrogen is the Biest 3.0 mg bioidentical cream; the placebo is the transdermal patch; the progesterone is compounded progesterone-100 mg	Drug	3
bioidentical hormone (Vivelle-Dot)Estrogen is the Vivelle-Dot patch 0.05 mg; the placebo is the transdermal cream; the progesterone is micronized progesterone-100 mg	Drug	4

Primary outcome

To measure estrone, estradiol and estriol levels at baseline and after achieving a steady state with 15-days of administration of three commonly used doses of bioidentical compounded estrogen cream and a standard dose conventional estrogen patch.
Time frame: Day 1 and Day 15
To measure the progesterone levels at baseline and after achieving a steady state with 15-days of administration of 100 mg/day of two different oral progesterone formulations.
Time frame: Day 1 and Day 15

3 secondary outcomes

To assess the feasibility of conducting a clinical trial randomizing patients to daily estradiol-estriol transdermal cream or biweekly estradiol patch for 15 days in 40 healthy postmenopausal women.
Time frame: Day 1 and Day 15
To assess the tolerability of use of daily estradiol-estriol transdermal cream and biweekly estradiol patch for 15 days in 40 healthy postmenopausal women in a randomized clinical trial.
Time frame: Day 1 and Day 15
To test if genetic variation in SULT1A1 copy number and single nucleotide polymorphisms (SNPs) influences estrogen pharmacokinetics in 40 healthy postmenopausal women receiving exogenous estrogen therapy.
Time frame: Day 1

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2012.
Derived from this study: PubMed 23384975Sood R, Warndahl RA, Schroeder DR, Singh RJ, Rhodes DJ, Wahner-Roedler D, Bahn RS, Shuster LT. Bioidentical compounded hormones: a pharmacokinetic evaluation in a randomized clinical trial. Maturitas. 2013 Apr;74(4):375-82. doi: 10.1016/j.maturitas.2013.01.010. Epub 2013 Feb 4.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Richa Sood, MD principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing bioidentical hormone (Biest) and bioidentical hormone (Vivelle-Dot) in people with Menopause, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To measure estrone, estradiol and estriol levels at baseline and after achieving a steady state with 15-days of administration of three commonly used doses of bioidentical compounded estrogen cream and a standard dose conventional estrogen patch. (time frame: Day 1 and Day 15). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00864214, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2012.