MenopausePhase 2/3NCT00775242
Efficacy and Safety of Estradiol and Progesterone Microspheres for the Treatment of Climacteric Symptoms.
A Phase 2/3 study testing Estradiol and Progesterone in people with Menopause, run by Centro A.F. de Estudios Tecnologicos, S.A. at 1 site in Mexico.
Trial summary
During menopause a woman's body slowly produces less of the hormones estrogen and progesterone. Lower hormone levels in menopause may lead to hot flashes, vaginal dryness and osteoporosis. To help with these problems, women are often given estrogen or estrogen with progestin. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Menopause
- What is being tested?
- Estradiol and Progesterone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteMexico
- Study dates
- Apr 2007to Nov 2008
- Phase
- Phase 2/3
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40 and 65 years.
- Perimenopausal subjects: Women showing spontaneous amenorrhea during the last 11 months.
- Postmenopausal subjects: Women with not less than 12 consecutive months of amenorrhea and FSH > 40 mIU/mL
- Subjects showing vasomotor symptoms, not less than 3 hot flashes in a day or not less than 21 hot flashes in a week
- Healthy subjects determined on the basis of a satisfactory complete clinical history, clinical laboratory tests, cervical cytology, endometrium biopsy and vaginal pelvic ultrasonography.
- Subjects not receiving any hormonal treatment.
Who cannot join
- Subjects with background of endometrial hyperplasia or endometrial cancer.
- Subjects with endometrial hyperplasia or endometrial cancer assessed by endometrial biopsy.
- Perimenopausal subjects with background of abnormal uterine bleeding unless the Principal Clinical Investigator considers that this abnormality is secondary to the menopausal condition.
- Subjects with hypersensitivity to any medicament.
- Subjects with direct family background of breast cancer.
- Subjects with background of cardiovascular disease, renal, hepatic, metabolic, gastrointestinal, neurologic, endocrine, gynecologic disease including dysfunctional uterine bleeding, cervico uterine dysplasia, cancer, anemia, emotional disorders, or any other chronic degenerative disorders which could affect her participation in the study.
- Subjects who require any medicament in the course of the study unless the Principal Clinical Investigator considers that there is no pharmacological interaction.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Centro A.F. de Estudios Tecnologicos, S.A.
Mexico City, Mexico City, 03100
About this study
Official title: Comparative Efficacy and Safety Study of Three Different Doses of a Formulation Composed of Crystalline Estradiol and Progesterone Microspheres, Indicated for Monthly IM Injection for the Treatment ot Climacteric Symptoms.
During menopause a woman's body slowly produces less of the hormones estrogen and progesterone. Lower hormone levels in menopause may lead to hot flashes, vaginal dryness and osteoporosis. To help with these problems, women are often given estrogen or estrogen with progestin. The purpose of this study is to assess and compare the efficacy and safety of three doses of estradiol and progesterone for the treatment of the climacteric symptoms
Read the detailed description
Different formulations of estrogens and progestins have been used for the treatment of climacteric symptoms, however up to this date no formulation is completely satisfactory. Our company has developed a new technology for the preparation of controlled release bioerodible non-polymeric microspheres, these microspheres are capable of delivering doses of estradiol (E) and progesterone (P) at levels appropriate for the Hormonal Replacement Therapy (HRT) in order to relieve the climacteric symptoms. Non clinical and clinical studies have been conducted aimed at assessing the pharmacokinetics of these microspheres, at several doses of progesterone and estradiol. Results show that sustained plasma profiles for both steroids within the therapeutic range for several days are attained. On this basis, a new efficacy and safety study is going to be conducted with the purpose of assessing and defining the most appropriate doses of estradiol and progesterone for the HRT of the climacteric symptoms.
Three different doses of progesterone and estradiol (0.5 mg of E + 15 mg of P vs 1 mg of E + 20 mg of P vs 1 mg of E + 30 mg of P) will be compared in terms of their efficacy and safety to treat the climacteric symptoms in healthy postmenopausal women.
- Conditions
- Menopause
- Being tested
- Estradiol and Progesterone
- Keywords
- Menopause, Hormone Replacement Therapy, Microspheres, Progesterone, Estradiol, Hot flashes
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol and ProgesteroneDrug
Also called estrogens and progestines
Injectable suspension of three different dosages of estradiol and progesterone a) 0.5 mg E/15 mg P; b) 1 mg E/20 mg P; c) 1 mg E/30 mg P. Administered on a monthly basis during a six-month period.
Estradiol and ProgesteroneDrug
Also called Estrogens, Progestins
Injectable suspension of three different formulations of estradiol and progesterone a) 0.5 mg E/15 mg P; b) 1 mg E/20 mg P; c) 1 mg E/30 mg P. Each will be applied on a monthly basis during a six-month period
| Study group | Role | What they receive |
|---|---|---|
| Estradiol and progesterone injection | Experimental | Comparison of three different dosages of estradiol and progesterone a) 0.5 mg E/15 mg P; b) 1 mg E/20 mg P; c) 1 mg E/30 mg P Receives: Drug: Estradiol and Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of frequency and intensity of vasomotor symptoms
Measured: 0, 1, 2, 3, 4, 5, 6 and 7 months
Secondary outcomes (1)
Frequency and intensity of vulvar and vaginal atrophy symptoms Vaginal pH Index of vaginal maturation (surface, intermediate and parabasal cells) Karyopiknotic index Lipids profile Utian quality of life scale Green climacteric symptoms scale
Measured: 0, 1, 2, 3, 4, 5, 6 and 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2008 (estimated)
- Study startApr 2007
- Primary completionNov 2008
- Study completionNov 2008
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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro A.F. de Estudios Tecnologicos, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Manuel Cortes Bonilla, Ob/Gyn, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00775242
- Sponsor's protocol ID
- 02/PAF/06
- Other IDs
- 0607/I/APL
- Status last verified
- Aug 2009
- First submitted
- 16 Oct 2008
- Last updated
- 25 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Cortes-Bonilla M, Alonso-Campero R, Bernardo-Escudero R, Francisco-Doce MT, Chavarin-Gonzalez J, Perez-Cuevas R, Chedraui P. Improvement of quality of life and menopausal symptoms in climacteric women treated with low-dose monthly parenteral formulations of non-polymeric microspheres of 17beta-estradiol/progesterone. Gynecol Endocrinol. 2016 Oct;32(10):831-834. doi: 10.1080/09513590.2016.1183628. Epub 2016 May 17.
PubMed 27187320
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy and Safety Study of Three Different Doses of a Formulation Composed of Crystalline Estradiol and Progesterone Microspheres, Indicated for Monthly IM Injection for the Treatment ot Climacteric Symptoms.
- ClinicalTrials.gov ID
- NCT00775242
- Acronym / sponsor ID
- 02/PAF/06
- Conditions
- Menopause
- Keywords
- Menopause, Hormone Replacement Therapy, Microspheres, Progesterone, Estradiol, Hot flashes
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Centro A.F. de Estudios Tecnologicos, S.A.Industry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 20 Oct 2008 (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.
During menopause a woman's body slowly produces less of the hormones estrogen and progesterone. Lower hormone levels in menopause may lead to hot flashes, vaginal dryness and osteoporosis. To help with these problems, women are often given estrogen or estrogen with progestin. The purpose of this study is to assess and compare the efficacy and safety of three doses of estradiol and progesterone for the treatment of the climacteric symptoms
Detailed description
Different formulations of estrogens and progestins have been used for the treatment of climacteric symptoms, however up to this date no formulation is completely satisfactory. Our company has developed a new technology for the preparation of controlled release bioerodible non-polymeric microspheres, these microspheres are capable of delivering doses of estradiol (E) and progesterone (P) at levels appropriate for the Hormonal Replacement Therapy (HRT) in order to relieve the climacteric symptoms. Non clinical and clinical studies have been conducted aimed at assessing the pharmacokinetics of these microspheres, at several doses of progesterone and estradiol. Results show that sustained plasma profiles for both steroids within the therapeutic range for several days are attained. On this basis, a new efficacy and safety study is going to be conducted with the purpose of assessing and defining the most appropriate doses of estradiol and progesterone for the HRT of the climacteric symptoms.
Three different doses of progesterone and estradiol (0.5 mg of E + 15 mg of P vs 1 mg of E + 20 mg of P vs 1 mg of E + 30 mg of P) will be compared in terms of their efficacy and safety to treat the climacteric symptoms in healthy postmenopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Estradiol and progesterone injection | Experimental | Drug: Estradiol and ProgesteroneComparison of three different dosages of estradiol and progesterone a) 0.5 mg E/15 mg P; b) 1 mg E/20 mg P; c) 1 mg E/30 mg P |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 40 and 65 years.
- Perimenopausal subjects: Women showing spontaneous amenorrhea during the last 11 months.
- Postmenopausal subjects: Women with not less than 12 consecutive months of amenorrhea and FSH > 40 mIU/mL
- Subjects showing vasomotor symptoms, not less than 3 hot flashes in a day or not less than 21 hot flashes in a week
- Healthy subjects determined on the basis of a satisfactory complete clinical history, clinical laboratory tests, cervical cytology, endometrium biopsy and vaginal pelvic ultrasonography.
Key exclusion criteria (7 listed)
- Subjects with background of endometrial hyperplasia or endometrial cancer.
- Subjects with endometrial hyperplasia or endometrial cancer assessed by endometrial biopsy.
- Perimenopausal subjects with background of abnormal uterine bleeding unless the Principal Clinical Investigator considers that this abnormality is secondary to the menopausal condition.
- Subjects with hypersensitivity to any medicament.
- Subjects with direct family background of breast cancer.
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 |
|---|---|---|
| Estradiol and ProgesteroneAlso: estrogens and progestinesInjectable suspension of three different dosages of estradiol and progesterone a) 0.5 mg E/15 mg P; b) 1 mg E/20 mg P; c) 1 mg E/30 mg P. Administered on a monthly basis during a six-month period. | Drug | Estradiol and progesterone injection |
| Estradiol and ProgesteroneAlso: Estrogens, ProgestinsInjectable suspension of three different formulations of estradiol and progesterone a) 0.5 mg E/15 mg P; b) 1 mg E/20 mg P; c) 1 mg E/30 mg P. Each will be applied on a monthly basis during a six-month period | Drug | Estradiol and progesterone injection |
Primary outcome
Change of frequency and intensity of vasomotor symptoms
Time frame: 0, 1, 2, 3, 4, 5, 6 and 7 months
1 secondary outcome
Frequency and intensity of vulvar and vaginal atrophy symptoms Vaginal pH Index of vaginal maturation (surface, intermediate and parabasal cells) Karyopiknotic index Lipids profile Utian quality of life scale Green climacteric symptoms scale
Time frame: 0, 1, 2, 3, 4, 5, 6 and 7 months
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 25 Aug 2009.
- Derived from this study: PubMed 27187320Cortes-Bonilla M, Alonso-Campero R, Bernardo-Escudero R, Francisco-Doce MT, Chavarin-Gonzalez J, Perez-Cuevas R, Chedraui P. Improvement of quality of life and menopausal symptoms in climacteric women treated with low-dose monthly parenteral formulations of non-polymeric microspheres of 17beta-estradiol/progesterone. Gynecol Endocrinol. 2016 Oct;32(10):831-834. doi: 10.1080/09513590.2016.1183628. Epub 2016 May 17.
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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.
Manuel Cortes Bonilla, Ob/Gyn principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Estradiol and Progesterone in people with Menopause, run by Centro A.F. de Estudios Tecnologicos, S.A. at 1 site in Mexico.
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 6 inclusion and 7 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 25 Aug 2009. 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 Mexico. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change of frequency and intensity of vasomotor symptoms (time frame: 0, 1, 2, 3, 4, 5, 6 and 7 months). 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 NCT00775242, 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 25 Aug 2009.