A Phase 1/2 interventional study of Transdermal estradiol gel 0.1% 1.5mg/ day and Transdermal estradiol gel 0.1% 2.0mg/ day in Primary Ovarian Insufficiency, sponsored by Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare. Status unknown at 1 site in Russian Federation. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-02-28.
Sponsored by Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare · Phase 1/2, Interventional, and Treatment
The goal of this study is to assess the effects of higher doses versus standard hormone therapy on quality of life (QoL), symptoms due to estrogen deficiency, and bone health in women with premature ovarian insufficiency (POI).
The efficacy of the hormonal treatment will be assessed clinically and also by measuring serum concentrations of Estradiol (E2), Follicle-Stimulating Hormone (FSH), Luteinizing hormone (LH), total Testosterone (T), Estrone (E1), E1 sulfate (E1S), and Sex Hormone Binding Globulin (SHBG). Bone mineral density (BMD) will be measured using dual-energy X-ray absorptiometry. Safety will be assessed by measuring endometrial thickness with Gynecological transvaginal ultrasound (TVS), treatment-related adverse events (AEs) and treatment-emergent AEs monitoring.
181 studies on the registry are indexed under Primary Ovarian Insufficiency; 48 are open to participants now.
This study's enrollment of 80 is above the median of 48 across 113 interventional studies indexed under Primary Ovarian Insufficiency.
Browse Primary Ovarian Insufficiency studies →Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient will be given Hormone Replacement Therapy (HRT) in the form of: Transdermal estradiol gel 0.1% 1.5mg (Gel sachet) in continuous daily regimen. The progesterone component of HRT (200mg micronized progesterone administered vaginally) will be given for 14 days, starting from day 14 through day 28 of each cycle.
Drug: Transdermal estradiol gel 0.1% 1.5mg/ day · Drug: Transdermal estradiol gel 0.1% 2.0mg/ day
Patient with insufficient effect from previous treatment estradiol gel 0.1% 1.5mg will be given HRT in the form of: Transdermal estradiol gel 0.1% 2.0mg (Gel sachet) in continuous daily regimen. The progesterone component of HRT (200mg micronized progesterone administered vaginally) will be given for 14 days, starting from day 14 through day 28 of each cycle.
Drug: Transdermal estradiol gel 0.1% 1.5mg/ day · Drug: Transdermal estradiol gel 0.1% 2.0mg/ day
Evaluation of the severity of estrogen deficiency symptoms
The Green scale questionnaire was used initially and after 3 months against the background of HRT. The questionnaire includes 21 questions from 0 to 3 points, where a lower score means a better result.
Time frame: 3 months
Changing the assessment of quality of life using the Short Form Health Survey-36 (SF-36)
The SF-36 is a generic QoL instrument. It consists of 36 items organized into eight domains: Physical Function (AF), Physical Role Function (RF), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Function (SF), Emotional Role Function (RE), and Mental Health (SM) as well as an item on the change of General Health. The scores of each domain have been converted into a scale from 0 to 100. Lower scores are indicative of worse conditions.
Time frame: 3 months
Changing the assessment of menopause-related quality of life measured using the Menopause-Specific Quality of Life (MENQOL) questionnaire.
The MENQOL questionnaire is a self-administered instrument. This validated questionnaire (range 1-8) assesses four quality of life domains; physical (16 items), vasomotor (3 items), psychosocial (7 items) and sexual (3 items). Scoring generates 4 domain scores and a total score, the mean of the 4 domain scores. Identical scoring for each of the four MENQOL domains is used. A "0" is identical that the woman has not experienced this specific symptom in the previous month; Score "1" demonstrates that the woman experienced the symptom, but it did not bother her; Scores "2" through "7" demonstrate an increasing level of the bothering symptom, so that these scores indicate increasing levels of bother experienced from the symptom and correspond to the ''1'' through ''6'' checkboxes on the MENQOL. With increasing MENQOL scores, levels of bother experienced from the symptom are increased as well.
Time frame: 3 months
Сhanges in the level of sex hormones after using higher doses estrogen therapy
Assessment of changes in the level of sex hormone in peripheral blood: estradiol (pmol/l). Reference values: 150 - 450 pmol/l. Blood sampling is performed at baseline and after 3 months.
Time frame: Assessment of changes in the level of sex hormone in peripheral blood: testosterone (nmol/l). Reference values: 0,52 - 2,5 nmol/l. Blood sampling is performed at baseline and after 3 months.
Сhanges in the level of sex hormones after using higher doses estrogen therapy
Assessment of changes in the level of sex hormone in peripheral blood: total testosterone (nmol/l). Reference values: 0,52 - 2,5 nmol/l. Blood sampling is performed at baseline and after 3 months.
Time frame: 3 months
Сhanges in the level of FSH after using higher doses estrogen therapy
Time frame: 3 months
Сhanges in the level of E1 after using higher doses estrogen therapy
Time frame: 3 months
Сhanges in the level of E1S after using higher doses estrogen therapy
Time frame: 3 months
Сhanges in the level of SHBG after using higher doses estrogen therapy
Time frame: 3 months
Bone mineral density (BMD) response to using higher doses estrogen therapy for 12 Months
Time frame: 12 Months
Started Mar 2019 (actual). Primary completion is estimated for Apr 2023, 49 months after the start.
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This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Estradiol
Primary Ovarian Insufficiency →
Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare