Female HypogonadismNCT07821086
Effects of Estrogen Therapy on Lipid Metabolism and Insulin Sensitivity in Hypogonadal Women
A study testing Estrogen in people with Female Hypogonadism, run by Khyber Medical University Peshawar at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Female Hypogonadism
- What is being tested?
- Estrogen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Dec 2025to 20 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18 to 50 years.
- Diagnosis of hypogonadism, including:
- Primary ovarian insufficiency (POI)
- Hypogonadotropic hypogonadism
- Early menopause
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Institute of Basic Medical Sciences
Peshawar, Khyber Pakhtunkhwa, 25100
About this study
Official title: Effects of Estrogen Therapy on Lipid Metabolism and Insulin Sensitivity in Hypogonadal Women: A Single-Group Pre-Post Experimental Study
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.
Read the 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.
- Conditions
- Female Hypogonadism
- Being tested
- Estrogen
- Keywords
- Female Hypogonadism, Lipid Metabolism, Estrogen Therapy, Insulin Sensitivity, Insulin Resistance, Lipid Profile, Estrogen Deficiency
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EstrogenDrug
Also called Estradiol Valerate ( 2 Mg)
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Estrogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to 3 Months
Secondary outcomes (1)
Change in a Serum Estrogen Level
Change in serum estrogen levels from baseline to 3 months following initiation of estrogen therapy.
Measured: Baseline to 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start4 Dec 2025
- Primary completion9 Jul 2026
- Study completion20 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Female HypogonadismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khyber Medical University Peshawar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mona Jamal, MPhil, Principal investigator, Khyber Medical University PeshawarMohsin Shah, PhD, Study director, Khyber Medical University Peshawar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821086
- Sponsor's protocol ID
- KMU/DIR/CTU/2026/11
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 37463488Dam 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.
PubMed 34726661Huang 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.
PubMed 35757391
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Estrogen Therapy on Lipid Metabolism and Insulin Sensitivity in Hypogonadal Women: A Single-Group Pre-Post Experimental Study
- ClinicalTrials.gov ID
- NCT07821086
- Acronym / sponsor ID
- KMU/DIR/CTU/2026/11
- Conditions
- Female Hypogonadism
- Keywords
- Female Hypogonadism, Lipid Metabolism, Estrogen Therapy, Insulin Sensitivity, Insulin Resistance, Lipid Profile, Estrogen Deficiency
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Khyber Medical University PeshawarUniversity, hospital or other
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- 9 Jul 2026 (actual)
- Study completion
- 20 Sep 2026 (estimated)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Estrogen therapy | Experimental | Drug: EstrogenParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women aged 18 to 50 years.
- Diagnosis of hypogonadism, including:
- Primary ovarian insufficiency (POI)
- Hypogonadotropic hypogonadism
- Early menopause
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EstrogenAlso: Estradiol Valerate ( 2 Mg)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. | Drug | Estrogen therapy |
Primary outcome
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.
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.
1 secondary outcome
Change in a Serum Estrogen Level
Time frame: Baseline to 3 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Background: PubMed 37463488Tebbens 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.
- Background: PubMed 34726661Dam 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.
- Background: PubMed 35757391Huang 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mona Jamal, MPhil principal investigator
Khyber Medical University Peshawar
Mohsin Shah, PhD study director
Khyber Medical University Peshawar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Estrogen in people with Female Hypogonadism, run by Khyber Medical University Peshawar at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lipid Profile (time frame: Baseline to 3 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07821086, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.