An interventional study of Estrogen in Female Hypogonadism, sponsored by Khyber Medical University Peshawar. Active, not recruiting at 1 site in Pakistan. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Khyber Medical University Peshawar · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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
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)
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.
Time frame: 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.
Time frame: Baseline to 3 Months
Change in a Serum Estrogen Level
Change in serum estrogen levels from baseline to 3 months following initiation of estrogen therapy.
Time frame: Baseline to 3 Months
Plan to share: Yes — De-identified individual participant data underlying the results reported in the study, including demographic and clinical characteristics and laboratory measurements related to lipid profile, fasting glucose, fasting insulin, HOMA-IR, and serum estrogen levels, may be shared with qualified researchers for scientifically valid research purposes.
Supporting information: Study protocol, Sap, Analytic code
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Khyber Medical University Peshawar