Trial · NCT01457703
Reproductive Hormonal Alterations in Obesity
NCT01457703, Not applicable, Completed, University of Colorado, Denver; results first posted 2015-03-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Reproductive Hormonal Alterations in Obesity. Trials, record NCT01457703. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01457703
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Reproductive Hormonal Alterations in Obesity
- NCT number
- NCT01457703
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 62 participants, actual
- Lead sponsor
- University of Colorado, Denver
- Conditions
- Obesity
- Interventions
- Cetrorelix, Gonadorelin-GnRH, Recombinant LH, Letrozole
- First posted
- 2011-10-24
- Last updated
- 2017-01-12
- Results first posted
- 2015-03-25
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 1) | Measured hourly and averaged over the 12 hour study visit | Luteinizing Hormone (LH) Pulse Amplitude was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups. |
| Primary | Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 2) | Measured hourly and averaged over the 12 hour study visit | Luteinizing Hormone (LH) Pulse Amplitude was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups. |
| Primary | Changes in Pregnanediol Glucuronide (PdG) (Aim 2) | Averaged over the length of menstrual cycle | Pregnanediol glucuronide (PdG) was collected daily over the course of one menstrual cycle and averaged. |
| Secondary | Changes in Follicle Stimulating Hormone (FSH) (Aim 1) | Measured hourly and averaged over the 12 hour study visit | Follicle-stimulating hormone was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups. |
| Secondary | Changes in Follicle Stimulating Hormone (FSH) (Aim 2) | Measured hourly and averaged over the 12 hour study visit | Follicle-stimulating hormone was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 1) | Measured hourly and averaged over the 12 hour study visit | This study was divided into two aims, and 10 obese and 10 normal weight women completed the study procedures and contributed data for analyses related to Aim 1. | IU/L | MEAN |
| PRIMARY | Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 2) | Measured hourly and averaged over the 12 hour study visit | This study was divided into two aims, and only 12 obese and 11 normal weight women completed the study procedures for Aim 2 that allowed measure of LH pulse amplitude. | IU/L | MEAN |
| PRIMARY | Changes in Pregnanediol Glucuronide (PdG) (Aim 2) | Averaged over the length of menstrual cycle | This study was divided into two aims, and only 12 obese and 10 normal weight women completed the urine collection study procedures for Aim 2 that allowed measure of PdG. | ug/cycle | MEAN |
| SECONDARY | Changes in Follicle Stimulating Hormone (FSH) (Aim 1) | Measured hourly and averaged over the 12 hour study visit | This study was divided into two aims, and only 10 obese and 10 normal weight women completed the study procedures for Aim 1 that allowed measure of FSH. | IU/L | MEAN |
| SECONDARY | Changes in Follicle Stimulating Hormone (FSH) (Aim 2) | Measured hourly and averaged over the 12 hour study visit | This study was divided into two aims, and only 12 obese and 11 normal weight women completed the study procedures for Aim 2 that allowed measure of FSH. | IU/L | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 1) | BMI ≥30 kg/m2 | 4.1 | Inter-Quartile Range 2.9 to 5.2 | IU/L | |
| Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 1) | BMI 18-25 kg/m2 | 3.6 | Inter-Quartile Range 2.7 to 9.9 | IU/L | |
| Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 2) | BMI ≥30 kg/m2 | 2.21 | Standard Deviation .32 | IU/L | |
| Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 2) | BMI 18-25 kg/m2 | 4.44 | Standard Deviation 1.03 | IU/L | |
| Changes in Pregnanediol Glucuronide (PdG) (Aim 2) | BMI ≥30 kg/m2 | 54.1 | Standard Deviation 33 | ug/cycle | |
| Changes in Pregnanediol Glucuronide (PdG) (Aim 2) | BMI 18-25 kg/m2 | 88.7 | Standard Deviation 64.6 | ug/cycle | |
| Changes in Follicle Stimulating Hormone (FSH) (Aim 1) | BMI ≥30 kg/m2 | 3.8 | Inter-Quartile Range 2.1 to 4.2 | IU/L | |
| Changes in Follicle Stimulating Hormone (FSH) (Aim 1) | BMI 18-25 kg/m2 | 3.3 | Inter-Quartile Range 3 to 4.9 | IU/L | |
| Changes in Follicle Stimulating Hormone (FSH) (Aim 2) | BMI ≥30 kg/m2 | 5.31 | Standard Deviation .38 | IU/L | |
| Changes in Follicle Stimulating Hormone (FSH) (Aim 2) | BMI 18-25 kg/m2 | 6.18 | Standard Deviation .94 | IU/L |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BMI ≥30 kg/m2 | 29 | |
| Overall Study | STARTED | BMI 18-25 kg/m2 | 33 | |
| Overall Study | COMPLETED | BMI ≥30 kg/m2 | 23 | |
| Overall Study | COMPLETED | BMI 18-25 kg/m2 | 22 | |
| Overall Study | NOT COMPLETED | BMI ≥30 kg/m2 | 6 | |
| Overall Study | NOT COMPLETED | BMI 18-25 kg/m2 | 11 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BMI ≥30 kg/m2 | ||
| Total, all-cause mortality | BMI 18-25 kg/m2 | ||
| Total, other adverse events | BMI ≥30 kg/m2 | 0 | 29 |
| Total, other adverse events | BMI 18-25 kg/m2 | 0 | 33 |
| Total, serious adverse events | BMI ≥30 kg/m2 | 0 | 29 |
| Total, serious adverse events | BMI 18-25 kg/m2 | 0 | 33 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U54HD058155 | Center for the Study of Reproductive Biology and Women's Health | POLLARD, JEFFREY W. | ALBERT EINSTEIN COLLEGE OF MEDICINE | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2009 to 2013 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| BMI ≥30 kg/m2 vs BMI 18-25 kg/m2: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01457703
GET https://conductscience.org/api/trials/v1/NCT01457703/registered