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Hormone Replacement Therapy clinical trials

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NCT ID: NCT04503915 Not yet recruiting - Clinical trials for Hormone Replacement Therapy

Estrogen Supplementation Mode in HRT-FET Cycle: a RCT

Start date: November 1, 2020
Phase: N/A
Study type: Interventional

A systematic review and meta-analysis concluded that there is insufficient evidence to recommend one particular protocol for HRT with regard to pregnancy rates after frozen embryo transfer, and no comparison of estrogen dose or route of administration was included in the review[7]. It is worth highlighting that the authors did not find any literature discussing the effect of estrogen dose and route of administration for HRT on reproductive outcomes. In 2016, a retrospective cohort study concluded that there is no difference in live birth rates between a constant dose versus an increasing dose of estrogen in oocyte donation cycles with oral or transdermal supplementation[6]. In order to provide good evidence about pattern of estrogen supplementation in HRT-FET, a randomized controlled study is urgently needed. The present randomized controlled study aims to compare between a constant estrogen dose protocol and a step-wise increasing estrogen dose protocol on the live birth rate of HRT-FET cycles.

NCT ID: NCT04478760 Recruiting - Clinical trials for Hormone Replacement Therapy

Trans & Non-binary Reference Intervals While on Hormone Therapy Study

TransRIHTS
Start date: April 13, 2021
Phase:
Study type: Observational

This study will find out what the reference intervals are for common blood tests in transgender people taking hormone therapy. Reference intervals help doctors interpret blood test results. They are expressed as two numbers, and most normal results fall between them. If a results fall outside of them, it may be because of a disease. Some blood tests are also affected by normal difference between people, such as age, sex or ethnicity. For these tests, different reference intervals are given for each group of people. Having accurate reference intervals benefits patients because it allows doctors to identify disease faster. Transgender people have a gender identity which does not match their sex characteristics at birth. Gender identity is the feeling of being a gender, and sex is the biological aspects of growing up male or female. Transgender people may use hormone therapy to help change their appearance to fit their gender identity. This involves taking either oestrogen or testosterone. For blood tests which are affected by sex, it is not clear what reference intervals should be used for transgender people who are on hormone therapy. This is because they have a mixture of male and female sex characteristics. Answering this question will allow doctors to identify disease in them faster. The study will take place at cliniQ, at King's College Hospital, which provides health services to transgender people. It will recruit healthy transgender people who attend the clinic for blood tests to monitor their hormone therapy. Participants will fill out a questionnaire, give a urine sample, then have their appointment as normal. Extra tests will also be performed on their blood sample. The aim is to recruit 240 participants. Participant's tests results will then be used to calculate reference intervals. The study is funded by Viapath Group LLP.

NCT ID: NCT04453332 Recruiting - Menopause Clinical Trials

Effects of Hormone Replacement Therapy on Cardiovascular Risk and Body Composition Parameters

Start date: October 9, 2015
Phase: N/A
Study type: Interventional

Menopause is defined as the last episode of menstrual bleeding, resulting from the interruption of ovarian function by follicular depletion. It is characterized by the presence of amenorrhea associated with increased levels of FSH and low levels of estradiol. The decline in estrogenic levels is associated with several organic changes, from vasomotor symptoms to impaired bone mass and urogenital atrophy. Although for some patients menopause is asymptomatic or oligosymptomatic, many women experience intense symptoms, which profoundly affect quality of life. Proper assessment and treatment of postmenopausal women can significantly improve climacteric symptoms. Target tissue, hormone therapy regimen and variations between patients will influence the effects of treatment. Regarding estrogen, the main factors that influence the therapeutic response are the type of hormone used, the dose and the route of administration. The skin metabolizes only a small part of estradiol. Thus, the transdermal route reaches adequate therapeutic levels from a lower dose of estrogen. The present study aims to evaluate and compare the effects of low dose of oral estradiol associated with oral progesterone and transdermal estradiol associated with vaginal progesterone on variables related to inflammation, coagulation and body composition parameters.

NCT ID: NCT01070979 Completed - Clinical trials for Hormone Replacement Therapy

Hormone Replacement Therapy for Use in Postmenopausal Women for Relief of Hot Flushes and Urogenital Symptoms.

Start date: February 2003
Phase: Phase 3
Study type: Interventional

Multicenter, double-blind, controlled, parallel group, randomized study to compare the clinical benefit of Estradiol acetate tablets, estradiol tablets and conjugated equine estrogen tablets, each administered orally, once daily, to postmenopausal women.

NCT ID: NCT01023802 Completed - Breast Cancer Clinical Trials

The Use of Molecular Breast Imaging in the Evaluation of Tumor Response to Neoadjuvant Therapy in Women With Breast Cancer

Start date: February 2009
Phase: N/A
Study type: Observational

In patients with breast cancer who undergo neoadjuvant chemotherapy or neoadjuvant hormone therapy molecular breast imaging (MBI) is an accurate test for assessing response rate to neoadjuvant therapy.

NCT ID: NCT00785317 Recruiting - Clinical trials for Hormone Replacement Therapy

Effects of Estradiol on Menopausal Breast

BrAVA
Start date: November 2008
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the effects on breast in postmenopausal women randomized to either oestradiol in combination with DRSP or E2 in combination with NETA during six months.

NCT ID: NCT00463450 Completed - Clinical trials for Hormone Replacement Therapy

Efficacy of Gynodian® Depot in Women With Impaired Well-being

Start date: May 2002
Phase: Phase 3
Study type: Interventional

The typical menopausal symptoms that are associated with a variety of physical and psychological changes (e.g. nervousness, anxiety, and depression) and also with impaired sexual interest and enjoyment are caused by a lack of estrogen, a female sex hormone produced inside the body. To treat these symptoms, women who are postmenopausal can receive a therapy called 'hormone replacement therapy' (the dosage of hormones to replace the body's deficient hormones), for instance, with estrogen preparations injected into a muscle.In women with a uterus estrogen use causes the lining of the womb (endometrium) to grow (thicken) as before the menopause. With long-term use this may lead to pathological changes of the endometrium. That is why this therapy should be complemented by the estrogens' natural counterbalance, progesterone (progestogen), at a certain interval. This causes the lining of the womb to shed, with monthly bleeding like a normal period, thus avoiding excessive endometrial growth.Estrogen treatment is well known to relieve psychological complaints. The combination of an estrogen with a weak androgen (in this case Dehydroepiandrosterone (DHEA)) is presumed to clearly increase this effect. The present clinical study is to prove that Gynodian? Depot as a combination of estrogen and androgen has a better effect on psychological complaints and sexuality in postmenopausal women than has treatment with the estrogen Estradiol valerate alone.All patients will receive the same therapy, but differing in sequence. Either they receive Gynodian? Depot during the first five cycles and the estrogen-only preparation during cycles 6-10 (treatment group 1) or they receive the study medication in reverse order (treatment group 2). Patients will be assigned to one of the two groups at random. In either case they will be given an injection into the gluteal muscle every four weeks.Women with an intact uterus, in addition to the injections (the day of the injection being the 1st day of a cycle) have to take a tablet containing 5 mg Medroxyprogesterone acetate (MPA) (progestogen) per day for 14 days (cycle days 15-28) to enable the endometrium to shed in a monthly period.The study will extend over a total period of about 11 months, during which the patient will have 16 appointments for examinations.After patient has signed on the informed consent form for participation in this clinical study, the investigator will ask her, which diseases she has at the moment or has had during the past 12 months and which medicinal products she has been taking. Subsequently, she will have a gynecological examination (including the breasts) as well as a general physical examination. Blood pressure, heart rate as well as body height and weight will be measured and noted down. In addition, the doctor will question her about physical and psychological menopausal complaints by means of two different, short questionnaires. Only if the evaluation of these two questionnaires shows that she is eligible for the participation in this clinical study, will the following actions be carried through.Approx. 40 ml blood will be taken from the patient for a thorough laboratory test including her hormone levels, and she will be asked for a urine sample. Additionally, she will have a vaginal ultrasound examination of the womb lining, a cervical smear test (unless already done during the last three months), and an x-ray examination of the breasts (mammography) (unless already done during the last 12 months).These measures will be repeated at Final visit.About 3 weeks after visit 1, when the investigator has the results of all tests prescribed at visit 1, the patient will be asked to appear for visit 2.If the patient is eligible for a participation in this clinical study, she will be given the first injection of the study medication.During the following visits, injections will be given, blood pressure and pulse rate as well as body weight will be measured and blood will be drawn to measure the hormone levels.All procedures will apply also during the second treatment period. When switching to the second treatment period a physical and gynecological examination will additionally be performed.Questionnaires have to be filled in by the patient at different time points during the study.

NCT ID: NCT00319072 Completed - Menopause Clinical Trials

Hormone Replacement Therapy (HRT) Website Tool

Start date: March 2004
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate a prototype web-based module for patients to generate appropriate and focused health information along with a customized set of questions to take to their health care provider for discussion on hormone replacement therapy.

NCT ID: NCT00012909 Completed - Menopause Clinical Trials

Development and Evaluation of a Hormone Replacement Therapy Decision-Aid

Start date: n/a
Phase: N/A
Study type: Interventional

The decision regarding the use of post-menopausal estrogen hormone replacement therapy (HT) is complex because patients must balance the short and long-term risks and benefits. Information from new and important clinical trials must also be considered. The purpose of this research is to develop and evaluate the efficacy of a HT CD-ROM decision-aid in improving the decision making process for women considering the use of estrogen HT.