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Active, not recruiting

NCT Number: NCT07821086

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Female Hypogonadism Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Basic Medical Sciences

Peshawar, Khyber Pakhtunkhwa, 25100, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Estradiol Valerate ( 2 Mg)

Primary outcomes

  1. Change in Lipid Profile

    Time frame: 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.

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

    Time frame: 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 outcomes

  1. Change in a Serum Estrogen Level

    Time frame: Baseline to 3 Months

    Change in serum estrogen levels from baseline to 3 months following initiation of estrogen therapy.

Interested in participating?

Active, not recruiting

This study is active but is not currently recruiting participants.

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Sponsors and collaborators

Lead sponsor

Khyber Medical University Peshawar

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 15, 2026
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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