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Trial · NCT07904208

Oral GDC-0077 in Premature Ovarian Insufficiency

NCT07904208, Phase 1, Not yet recruiting, Women's Hospital School Of Medicine Zhejiang University

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Oral GDC-0077 in Premature Ovarian Insufficiency. Trials, record NCT07904208. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07904208

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Oral GDC-0077 in Premature Ovarian Insufficiency
NCT number
NCT07904208
Status
Not yet recruiting
Phases
Phase 1
Enrollment
12 participants, estimated
Lead sponsor
Women's Hospital School Of Medicine Zhejiang University
Conditions
Primary Ovarian Insufficiency
Interventions
GDC-0077
First posted
2026-10-29
Last updated
2026-10-29

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryIncidence of treatment-emergent adverse events (TEAEs), including hyperglycemia, stomatitis/mucositis, and diarrhea3 months
Proportion of participants experiencing any TEAE, serious adverse event (SAE), and AEs of special interest (fasting glucose elevation, oral stomatitis/mucositis, diarrhea), graded by CTCAE v5.0. Fasting glucose will be monitored weekly during the first month after treatment initiation; other AEs will be captured throughout the 3-month follow-up.
PrimaryChange in total antral follicle count (AFC) from baseline to 3 months after treatment initiationBaseline and 3 monthsTotal AFC (both ovaries) assessed by transvaginal ultrasound. Baseline AFC will be recorded during screening (D-28 to D-1).
SecondaryProportion of participants with ≥1 antral follicleBaseline and 3 monthsMeasured by ultrasound
SecondaryProportion of participants with ≥1 dominant follicleBaseline and 3 monthsMeasured by ultrasound
SecondaryChange in ovarian volumeBaseline and 3 monthsMeasured by ultrasound
SecondaryChange in serum FSH, LH levels (IU/L)Baseline and 3 monthsChange in serum FSH, LH levels (IU/L)
SecondaryProportion of participants achieving FSH <25 IU/L3 monthsProportion of participants achieving FSH \<25 IU/L
SecondaryProportion of participants with ≥1 spontaneous menses (non-HRT-induced)3 monthsProportion of participants with ≥1 spontaneous menses (non-HRT-induced)
SecondaryIVF outcomes, if applicable: oocytes retrieved, transferable embryos, good-quality embryos, pregnancy outcomesthrough study completion, an average of 1 yearIVF outcomes, if applicable: oocytes retrieved, transferable embryos, good-quality embryos, pregnancy outcomes
SecondaryChange in serum E2 levels (pmol/L)Baseline and 3 monthsChange in serum E2 levels (pmol/L)

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

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 totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

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.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT07904208

GET https://conductscience.org/api/trials/v1/NCT07904208/registered