Hormone Replacement Therapy

8

Review clinical trials related to Hormone Replacement Therapy. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Menopause Effects on Cortico-reticular Functioning

Post-menopausal women who request to begin hormone-replacement therapy (HRT) are directed to the research team. The participants are tested before beginning HRT, after two months of HRT, and five months of HRT. Tests include strength performance, central nervous system functioning, body composition, resting metabolic rate, and vascular screening. The participants are provided a 12-week training intervention (2 x strength, 2 x endurance per week) that can be voluntarily followed between tests at month 2 and 5. Compliance with the training program is recorded. A minimum of 15 participants are needed a priori, but the investigators aim to recruit and test 20 women.

Participants needed: 20
Trial details
Age: 50-59Biological sex: FemaleType: InterventionalSponsor: University of JyvaskylaUpdated: May 1, 2026Locations: 1
Eligibility criteria

at least 6 months since their last period but no more than being 5 years post-me... [+5]

classified as excessively obese via BMI assessment (i.e., >35 kg/m2) [+6]

Status: Not yet recruiting

Impact of New Hormone Replacement Therapy After Menopause on Heart Health in Women

This prospective registry study investigates the impact of new hormone replacement therapy (HRT) delivery methods, such as creams, gels, and sprays, on cardiovascular risk in postmenopausal women. Menopause-related estrogen deficiency leads to metabolic and vascular changes that increase atherosclerosis and cardiovascular events. This study hypothesizes that new HRT forms may reduce cardiovascular risk in high-risk women."

Participants needed: 2,725
Trial details
Age: 45-75Biological sex: FemaleType: ObservationalSponsor: Heinrich-Heine University, DuesseldorfUpdated: Feb 10, 2026Locations: 2
Eligibility criteria

Age 45-75 years [+4]

Age <45 years / > 75 years [+5]

Status: Recruiting

Letrozole-stimulated Cycle Strategy Versus Artificial Cycle Strategy (LETSACT)

The goal of this randomized clinical trial is to evaluate the effectiveness of the letrozole-stimulated cycle strategy versus the artificial cycle strategy for endometrial preparation in women with irregular menstrual cycles after one cycle of endometrial preparation. The primary question it aims to answer is: • Does the letrozole-stimulated cycle strategy for endometrial preparation result in a higher live birth rate compared to the artificial cycle strategy in women with irregular menstrual cycles after one cycle of endometrial preparation? Participants will undergo screening before endometrial preparation for frozen embryo transfer, following which they will be randomly assigned to one of two groups: LETS or AC. In the LETS group, investigators will prescribe letrozole 5 milligrams/day for 5 days to stimulate follicular development and micronized progesterone 800 milligrams/day for luteal phase support. In contrast, the AC group will receive oral estradiol valerate 6-12 milligrams/day and micronized progesterone 800 milligrams/day. Researchers will compare the LETS and AC groups to determine if there are differences in live birth rates.

Participants needed: 790
Trial details
Age: 18-42Biological sex: FemaleType: InterventionalSponsor: Mỹ Đức HospitalUpdated: Sep 25, 2025Locations: 2
Eligibility criteria

Aged between 18 - 42. [+4]

Allergy to letrozole or Ovitrelle or oral estradiol valerate or micronized proge... [+6]

Status: Not yet recruiting

Resting Energy Expenditure in Postmenopausal Women

Obesity and its associated comorbidities are rising at an alarming rate, particularly among postmenopausal women. Menopause, characterized by a decline in estradiol and progesterone levels, is often accompanied by weight gain. Fear of this weight gain is a major reason why many women hesitate to initiate or continue menopausal hormone therapy (MHT), with discontinuation often occurring within the first few months. However, scientific evidence on whether MHT influences weight gain remains inconclusive. A Cochrane Review found no significant effect of estrogen or combined estrogen-progestogen therapy on menopause-related weight gain, suggesting that aging and lifestyle changes play a more prominent role. While the effects of estrogen on energy intake have been well-documented, data on its impact on energy expenditure-particularly resting energy expenditure (REE), the largest component of total energy expenditure-are scarce. Several studies suggest that sex hormones may influence REE, as observed in premenopausal women, where REE increases during the luteal phase when estradiol and progesterone levels are high. However, findings on this topic remain inconsistent, and it is unclear whether estrogen or progesterone plays the primary role. Research on the effects of exogenous hormone administration, such as MHT, on REE is extremely limited, with existing studies producing mixed results. Additionally, the potential influence of progestogens on REE has been largely overlooked. Given that a low REE is a strong predictor of weight gain and obesity, understanding the effects of MHT on REE is crucial. This observational clinical trial aims to investigate the precise effect of MHT (estradiol + progesterone) on REE in postmenopausal women with an indication for MHT. Secondary objectives include examining MHT's impact on energy intake, physical activity energy expenditure, performance capacity, body composition, core body temperature, serum hormone profiles (luteinizing hormone, follicle-stimulating hormone, estradiol, progesterone), glucose metabolism, fasting blood lipid levels, and miRNA expression (miR-370 and miR-29b, which are involved in lipid and glucose metabolism). Additionally, the study will assess various aspects of subjective well-being and quality of life. By addressing the current gaps in scientific knowledge, this study seeks to provide robust evidence on the role of MHT in energy metabolism, potentially reshaping perspectives on its risks and benefits in postmenopausal women.

Participants needed: 37
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: Insel Gruppe AG, University Hospital BernUpdated: Apr 2, 2025Locations: 1Duration: 6 Weeks
Eligibility criteria

Informed Consent as documented by signature [+5]

Pregnancy or Lactation [+10]

Status: Recruiting

Assessment of Endometrial Thickness Among Adolescent and Young Adult Patients on Estrogen Replacement Therapy Using Daily Oral Micronized Progesterone Versus the Etonogestrel Implant.

The goal of this observational study is to compare endometrial stripe thickness in adolescent and young adult (AYA) patients with a uterus on estrogen replacement therapy using oral progesterone versus the etonogstrel implant for endometrial protection. The main questions it aims to answer are: Aim 1: Characterize the mean endometrial thickness in AYA on estrogen hormone replacement therapy before initiation of progesterone therapy Aim 2: Characterize the mean changes and variability in endometrial thickness in AYA treated for 6 months with either the etonogestrel implant or continuous oral progesterone Aim 3: Assess satisfaction, side effects, bleeding patterns, any progesterone modifications, and adherence in AYA treated for 6 months with either etonogestrel implant or continuous progesterone Participants will be asked to: * Get two pelvic ultrasounds * Fill out two surveys * Continue their current hormone replacement therapy * Initiate one of two progesterone therapies (prometrium 100mg daily or Nexplanon) Researchers will compare the change in endometrial thickness after 6 months of progesterone use to see if there is a significant difference in the mean change between the prometrium and Nexplanon groups.

Participants needed: 34
Trial details
Age: 12-25Biological sex: FemaleType: ObservationalSponsor: University of Colorado, DenverUpdated: Dec 6, 2024Locations: 1Duration: 6 Months
Eligibility criteria

Age 12-25 years at baseline [+5]

Uterine abnormality (e.g., Müllerian Anomaly, uterine fibroids) [+3]

Status: Not yet recruiting

HISTOLOGICAL RESULTS IN TRANSGENDER INDIVIDUALS ASSIGNED TO FEMALES AT BIRTH UNDERGOING GENDER AFFIRMATION SURGERY AND IN TESTOSTERONE THERAPY

The aim of this study is to report histological results of genital organs removed during gender affirmg surgery in transgender people assigned female at birth (AFAB), to increase the knowledge about the long-term effects of gender affirming hormone therapy with testosterone on these organs and to evaluate the incidence of benign and malign gynecological pathology in AFAB transgender people.

Participants needed: 100
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: IRCCS Azienda Ospedaliero-Universitaria di BolognaUpdated: Nov 29, 2024Locations: 1
Eligibility criteria

gender incongruence diagnosis [+4]

previous gynecological surgery [+1]

Status: Recruiting

Determining Dose Equivalence Between Oral and Transdermal Estrogen Treatment in Women With Turner Syndrome

This 5-week, phase IV randomized crossover trial aims to compare the effects of oral versus transdermal estrogen replacement therapy (ERT) in women with Turner syndrome (TS). The objective is to establish the equipotency between the two estradiol regimens by evaluating various estradiol-dependent surrogate markers. The study involves 50 women with TS, aged 18-50 years, who are randomized to receive either oral or transdermal ERT for 14 days, followed by a crossover to the alternate treatment for another 14 days, with a one-week washout period in between. Blood tests are conducted at baseline, after the first 14 days of treatment, after the washout period, and after the final 14 days of treatment. The investigators anticipate that this study will provide clinicians with a better understanding of ERT in treating women with TS.

Participants needed: 50
Trial details
Phase: Phase 4Age: 18-50Biological sex: FemaleType: InterventionalSponsor: Aarhus University HospitalUpdated: Aug 23, 2024Locations: 1
Eligibility criteria

Diagnosis of TS regardless of karyotype [+2]

Active systemic chronic diseases [+7]

Status: Recruiting

Long Term Effects of Oral Versus Transdermal Estrogen Replacement Therapy in Turner Syndrome

This 14-month, phase IV, randomized controlled crossover trial aims to compare the effects of oral versus transdermal estrogen replacement therapy (ERT) in women with Turner syndrome (TS). The study's objectives are to clarify endocrine, metabolic, cardiovascular, and thromboembolic risk factors in TS after a wash-out period without estrogen (E2) treatment; compare the effects of oral versus transdermal (TD) ERT regimens; and examine the long-term effects of E2 administration via these two routes. The study involves 50 TS women aged 18-50 years and 50 control participants. TS participants are randomized to receive either oral or TD ERT for six months, followed by crossover to the alternate treatment for another six months. Prior to randomization, any existing ERT will be discontinued for a 1-month washout period. A second 1-month washout period will occur between the two 6-month treatment phases. Laboratory analyses and clinical investigations are performed after the first wash-out period, after the first six months of treatment, and after the last six months of treatment. We anticipate that this study may provide a basis for new and improved recommendations for sex hormone replacement therapy in TS.

Participants needed: 50
Trial details
Phase: Phase 4Age: 18-50Biological sex: FemaleType: InterventionalSponsor: Aarhus University HospitalUpdated: Aug 26, 2024Locations: 1
Eligibility criteria

Diagnosis of TS regardless of karyotype [+8]

Active systemic chronic diseases [+8]