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

Effects of Estrogen Therapy on Lipid Metabolism and Insulin Sensitivity in Hypogonadal Women: A Single-Group Pre-Post Experimental Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07821086

Enrollment

Registered

2026-09-15

Start date

2025-12-04

Completion date

2026-09-20

Last updated

2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female Hypogonadism

Keywords

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

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.

Detailed description

Female hypogonadism is characterised by reduced ovarian function and estrogen deficiency and may be associated with metabolic alterations, including disturbances in lipid metabolism and insulin sensitivity. Estrogen therapy is used to restore estrogen levels in women with estrogen deficiency; however, the short-term metabolic effects of estrogen therapy in women with hypogonadism require further evaluation. This single-group pre-post experimental study will evaluate changes in lipid metabolism and insulin sensitivity among hypogonadal women receiving oral estrogen therapy. Eligible participants will undergo baseline assessment before initiation of estrogen therapy and will be reassessed following the treatment period. Serum estrogen levels, fasting glucose, fasting insulin, and lipid profile, including total cholesterol, LDL-C, HDL-C, and triglycerides, will be measured at baseline and follow-up. Insulin sensitivity will be assessed using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) index. The study will assess changes in these metabolic parameters following estrogen therapy and provide evidence regarding its short-term effects on lipid metabolism and glucose-insulin regulation in hypogonadal women. The findings may contribute to a better understanding of the metabolic response to estrogen therapy and inform future research on the management of metabolic risks associated with estrogen deficiency.

Interventions

DRUGEstrogen

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Masking description

This is a single-arm, open-label, pre-post study. Participants, care providers, investigators, and outcomes assessors will not be masked.

Intervention model description

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.

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Change in Lipid Profile	Baseline to 3 Months	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.
Change in Insulin Sensitivity (HOMA-IR) from Baseline to 3 Months	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.

Secondary

Measure	Time frame	Description
Change in a Serum Estrogen Level	Baseline to 3 Months	Change in serum estrogen levels from baseline to 3 months following initiation of estrogen therapy.

Countries

Pakistan

Contacts

PRINCIPAL_INVESTIGATORMona Jamal, MPhil

Khyber Medical University Peshawar

STUDY_DIRECTORMohsin Shah, PhD