Effects of Estrogen Therapy on Lipid Metabolism and Insulin Sensitivity in Hypogonadal Women

NCT07821086 | Active Not Recruiting DMC

• 1 other identifier: KMU/DIR/CTU/2026/11
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the short-term effects of estrogen therapy on lipid metabolism and insulin sensitivity in hypogonadal women. Participants receiving estrogen therapy will be assessed before initiation of treatment and after the treatment period to determine changes in serum estrogen levels, fasting glucose, fasting insulin, and lipid profile. Insulin sensitivity will be assessed using the HOMA-IR index. The findings may contribute to a better understanding of the short-term metabolic effects of estrogen therapy in women with hypogonadism.

Conditions

Female Hypogonadism

Keywords

Female Hypogonadism; Lipid Metabolism; Estrogen Therapy; Insulin Sensitivity; Insulin Resistance; Lipid Profile; Estrogen Deficiency

Outcome Measures

Primary Outcomes (2)

• Change in Lipid Profile

  Change in total cholesterol, LDL-C, HDL-C, and triglyceride levels from baseline (before initiation of estrogen therapy) to 3 months after initiation of estrogen therapy.

  Baseline to 3 Months

• Change in Insulin Sensitivity (HOMA-IR) from Baseline to 3 Months

  Change in insulin resistance estimated using the HOMA-IR index from baseline (before initiation of estrogen therapy) to 3 months after initiation of estrogen therapy. HOMA-IR will be calculated from fasting glucose and fasting insulin measurements.

  Baseline to 3 Months

Secondary Outcomes (1)

• Change in a Serum Estrogen Level

  Baseline to 3 Months

Study Arms (1)

Estrogen therapy

EXPERIMENTAL

Participants with hypogonadism who have not previously started estrogen therapy will receive estrogen therapy as prescribed by their treating healthcare professional. Participants will undergo assessment at baseline before initiation of therapy and again after 3 months of treatment. Changes in lipid profile parameters (total cholesterol, LDL-C, HDL-C, and triglycerides) and insulin sensitivity, assessed using fasting glucose, fasting insulin, and HOMA-IR, will be evaluated between baseline and 3 months. Adverse events and treatment-related complications will also be recorded during the follow-up period.

Drug: Estrogen

Interventions

Estrogen DRUG

strogen therapy will be administered to women with hypogonadism as prescribed by a healthcare professional. Estrogen may be administered using oral or transdermal formulations at the prescribed dosage. Participants will receive therapy for 3 months, with assessments performed at baseline before initiation of therapy and after 3 months of treatment. The effects of estrogen therapy on lipid metabolism and insulin sensitivity will be evaluated using lipid profile parameters, fasting glucose, fasting insulin, and HOMA-IR. Serum estrogen levels will also be assessed during follow-up, and adverse events or treatment-related complications will be recorded.

Also known as: Estradiol Valerate ( 2 Mg)

Estrogen therapy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Women who meet the study eligibility criteria are eligible to participate
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 18 to 50 years.
• Diagnosis of hypogonadism, including:
• Primary ovarian insufficiency (POI)
• Hypogonadotropic hypogonadism
• Early menopause

You may not qualify if:

• Contraindications to estrogen therapy, including a history of thromboembolic events or certain hormone-sensitive cancers.
• Pre-existing conditions that may significantly affect lipid metabolism or insulin sensitivity.
• Use of medications known to affect lipid metabolism or insulin sensitivity.
• Pregnancy or lactation.

Sponsors & Collaborators

• Khyber Medical University Peshawar: lead

Study Sites (1)

Institute of Basic Medical Sciences

Peshawar, Khyber Pakhtunkhwa, 25100, Pakistan

Location

Related Publications (3)

• Tebbens M, Schutte M, Troelstra MA, Bruinstroop E, de Mutsert R, Nederveen AJ, den Heijer M, Bisschop PH. Sex Steroids Regulate Liver Fat Content and Body Fat Distribution in Both Men and Women: A Study in Transgender Persons. J Clin Endocrinol Metab. 2023 Dec 21;109(1):e280-e290. doi: 10.1210/clinem/dgad409.

  PMID: 37463488 BACKGROUND

• Dam TV, Dalgaard LB, Thomsen CB, Hjortebjerg R, Ringgaard S, Johansen FT, Bengtsen MB, Mose M, Lauritsen KM, Sondergaard E, Gravholt CH, Hansen M. Estrogen modulates metabolic risk profile after resistance training in early postmenopausal women: a randomized controlled trial. Menopause. 2021 Nov 1;28(11):1214-1224. doi: 10.1097/GME.0000000000001841.

  PMID: 34726661 BACKGROUND

• Huang L, Wang H, Shi M, Kong W, Jiang M. Lipid Profile in Patients With Primary Ovarian Insufficiency: A Systematic Review and Meta-Analysis. Front Endocrinol (Lausanne). 2022 Jun 10;13:876775. doi: 10.3389/fendo.2022.876775. eCollection 2022.

  PMID: 35757391 BACKGROUND

MeSH Terms

Conditions

Insulin Resistance

Interventions

Estrogens; Estradiol

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• Mona Jamal, MPhil

  Khyber Medical University Peshawar

  PRINCIPAL INVESTIGATOR

• Mohsin Shah, PhD

  Khyber Medical University Peshawar

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is a single-arm, open-label, pre-post study. Participants, care providers, investigators, and outcomes assessors will not be masked.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Single-arm, prospective, pre-post experimental study will be conducted. Participants will receive estrogen therapy and will be assessed at baseline before initiation of therapy and again after 3 months of therapy to evaluate changes in lipid metabolism and insulin sensitivity.

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 15, 2026
• Study Start: December 4, 2025
• Primary Completion: July 9, 2026
• Study Completion: September 20, 2026
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available after publication of the study results and will remain available for up to 5 years.
• Access Criteria: Data may be shared with qualified researchers upon submission of a scientifically sound research proposal and approval by the principal investigator and relevant institutional or ethical authorities. Data will be provided in de-identified form, subject to applicable ethical and institutional requirements.

Locations

PA (1)