Trial · NCT07914062
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Serum Estradiol Maintained Within 20-50 pg/mL for at Least 14 Consecutive Days | From Day 1 to Day 197 | Serum estradiol (E2) will be measured using a validated assay at the central laboratory at baseline, Days 1, 2, 8, 15, 22 and 29, and monthly through Day 197. A participant will be classed as a responder if E2 remains within 20-50 pg/mL inclusive (the estradiol therapeutic window described by Barbieri) for at least 14 consecutive days, as derived according to the Statistical Analysis Plan. The number and percentage of responders will be reported by treatment arm. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Teverelix | Day 1 (pre-dose) and Days 2, 8, 15, 22, 29, 57, 85, 113, 141, 169, 197, 281 and 365 | Cmax (ng/mL) derived by non-compartmental analysis of plasma teverelix concentrations, measured using a validated analytical method at a specialised laboratory, following a single SC or IM dose of Teverelix DP. Reported by treatment arm. |
| Secondary | Time to Maximum Observed Plasma Concentration (Tmax) of Teverelix | Day 1 (pre-dose) and Days 2, 8, 15, 22, 29, 57, 85, 113, 141, 169, 197, 281 and 365 | Tmax (hours) derived by non-compartmental analysis of plasma teverelix concentrations, measured using a validated analytical method at a specialised laboratory, following a single SC or IM dose of Teverelix DP. Reported by treatment arm. |
| Secondary | Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of Teverelix | Day 1 (pre-dose) and Days 2, 8, 15, 22, 29, 57, 85, 113, 141, 169, 197, 281 and 365 | AUC0-t derived by non-compartmental analysis of plasma teverelix concentrations, measured using a validated analytical method at a specialised laboratory, following a single SC or IM dose of Teverelix DP. Reported by treatment arm. |
| Secondary | Change From Baseline in Serum Estradiol Concentration | Baseline (Day 1 pre-dose) and Days 2, 8, 15, 22, 29, 57, 85, 113, 141, 169, 197, 281 and 365 | Serum estradiol (pg/mL) measured using a validated assay at the central laboratory. Baseline is the Day 1 pre-dose value. Reported by treatment arm. |
| Secondary | Change From Baseline in Serum Luteinising Hormone (LH) Concentration | Baseline (Day 1 pre-dose) and Days 2, 8, 15, 22, 29, 57, 85, 113, 141, 169, 197, 281 and 365 | Serum LH (IU/L) measured using a validated assay at the central laboratory. Baseline is the Day 1 pre-dose value. Reported by treatment arm. |
| Secondary | Change From Baseline in Serum Follicle-Stimulating Hormone (FSH) Concentration | Baseline (Day 1 pre-dose) and Days 2, 8, 15, 22, 29, 57, 85, 113, 141, 169, 197, 281 and 365 | Serum FSH (IU/L) measured using a validated assay at the central laboratory. Baseline is the Day 1 pre-dose value. Reported by treatment arm. |
| Secondary | Duration of Serum Estradiol Within 20-50 pg/mL | Day 1 to Day 197 | Number of days from the first to the last consecutive serum estradiol value within 20-50 pg/mL during the treatment period, measured using a validated assay at the central laboratory and derived according to the Statistical Analysis Plan. Reported by treatment arm |
| Secondary | Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BAP) | Baseline (Day 1 pre-dose) and Days 29, 57, 85, 113, 141, 169, 197, 281 and 365 | Serum BAP concentrations (ng/mL) measured using a validated assay at the central laboratory. Percent change from baseline is calculated for each post-baseline visit, where baseline is the Day 1 pre-dose value. Reported by treatment arm. |
| Secondary | Percent Change From Baseline in Urinary N-Telopeptide of Type I Collagen (NTx) | Baseline (Day 1 pre-dose) and Days 29, 57, 85, 113, 141, 169, 197, 281 and 365 | Urinary NTx (nmol BCE/mmol creatinine) measured using a validated assay at the central laboratory. Percent change from baseline is calculated for each post-baseline visit, where baseline is the Day 1 pre-dose value. Reported by treatment arm. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Day 1 through Day 365 | Adverse events will be coded using MedDRA and severity graded according to CTCAE v6.0. Reported by treatment arm. |
| Secondary | Number of Participants with Serious Adverse Events (SAEs) | Day 1 through Day 365 | Serious adverse events coded using MedDRA. Reported by treatment arm |
| Secondary | Number of Participants with Clinically Significant Abnormal Laboratory Values | Baseline (Day 1 pre-dose) and Days 15, 29, 57, 85, 113, 141, 169, 197, 281 and 365 | Fasted haematology, biochemistry and coagulation tests and urinalysis, with abnormal values judged clinically significant by the investigator. Reported by treatment arm. |
| Secondary | Number of Participants with Clinically Significant 12-Lead ECG Abnormalities | Baseline (Day 1 pre-dose) and Days 15, 29, 57, 85, 113, 141, 169, 197, 281 and 365 | Triplicate 12-lead ECGs, with findings judged clinically significant by the investigator. On Day 1, ECGs are recorded pre-dose and 2 hours post-dose. Reported by treatment arm. |
| Secondary | Change From Baseline in Dysmenorrhoea Score on the Biberoglu and Behrman (B&B) Scale | Baseline (Day 1) and Days 29, 57, 85, 113, 141, 169, 197, 281 and 365 | Dysmenorrhoea severity rated using the patient symptom component of the B\&B scale (0 = absent to 3 = severe); higher scores indicate more severe symptoms. Reported by treatment arm. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07914062/registered