Who is sponsoring NCT00445887?

NCT00445887 is sponsored by Gynecologic Oncology Group.

What drugs are being tested in NCT00445887?

Interventions in NCT00445887: Laboratory Biomarker Analysis, Levonorgestrel, Placebo.

What condition does NCT00445887 study?

NCT00445887 studies Ovarian Carcinoma.

Is NCT00445887 still recruiting?

NCT00445887 is currently completed. Last updated 19 November 2019.

Are results published for NCT00445887?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-11-19 · How we verify

NCT00445887

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Levonorgestrel in Preventing Ovarian Cancer in Patients at High Risk for Ovarian Cancer

Completed Phase 2 Results posted Last updated 19 November 2019

What this trial tests

Phase 2 trial testing Laboratory Biomarker Analysis in Ovarian Carcinoma in 60 participants. Completed.

Timeline

10 March 2008

Primary endpoint
11 December 2013

Quick facts

Lead sponsor	Gynecologic Oncology Group
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	60
Start date	10 March 2008
Primary completion	11 December 2013
Sites	66 locations across United States

Drugs / interventions tested

Laboratory Biomarker Analysis — full drug profile →
Levonorgestrel (LEVONORGESTREL) — full drug profile →
Placebo

Conditions studied

Ovarian Carcinoma — all drugs for Ovarian Carcinoma →

Sponsor

Gynecologic Oncology Group — full company profile →

Who can join

30 and older, female only, with Ovarian Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Median Proportion Cells That Are Apoptotic in Epithelial Ovarian Tissue Primary · Surgical specimen (4 - 6 weeks after entry)

The median proportion of cells that are considered to be apoptotic are counted in the ovarian tissue sample, among the total number of cells available in the sample slide.

Group	Value	95% CI
Arm I (Levenorgestrel)	.093	.024 – .25
Arm II (Placebo)	.115	.033 – .329

Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 Primary · Up to 20 weeks

Participants were graded using CTCAE v.30 criteria. Grade 1 is the least severe grade. Each adverse event lists criteria for grading, grade 1 being mild, up to grade 5. Grade 4 is generally life threatening. Grade 5 is death.

Allergy/Immunology

Group	Value	95% CI
Grade 1 CTCAE v 3.0 Arm I (Levonorgestrel)	1
Grade 2 CTCAE v 3.0 Arm 1 (Levonorgestrel)	0
Grade 3 CTCAE v 3.0 Arm 1 (Levonorgestrel)	0
Grade 4 CTCAE v3.0 Arm 1 Levonorgestrel)	0
Grade 5 CTCAE v3.0 Arm I (Levonorgestrel)	0
Grade 1 CTCAE 3.0 Arm II (Placebo)	0
Grade 2 CTCAE 3.0 Arm II (Placebo)	1
Grade 3 CTCAE 3.0 Arm II (Placebo)	0
Grade 4 CTCAE 3.0 Arm II (Placebo)	0
Grade 5 CTCAE 3.0 Arm II (Placebo)	0

Constitutional Symptoms

Group	Value	95% CI
Grade 1 CTCAE v 3.0 Arm I (Levonorgestrel)	1
Grade 2 CTCAE v 3.0 Arm 1 (Levonorgestrel)	0
Grade 3 CTCAE v 3.0 Arm 1 (Levonorgestrel)	0
Grade 4 CTCAE v3.0 Arm 1 Levonorgestrel)	0
Grade 5 CTCAE v3.0 Arm I (Levonorgestrel)	0
Grade 1 CTCAE 3.0 Arm II (Placebo)	0
Grade 2 CTCAE 3.0 Arm II (Placebo)	1
Grade 3 CTCAE 3.0 Arm II (Placebo)	0
Grade 4 CTCAE 3.0 Arm II (Placebo)	0
Grade 5 CTCAE 3.0 Arm II (Placebo)	0

Cardiac

Group	Value	95% CI
Grade 1 CTCAE v 3.0 Arm I (Levonorgestrel)	1
Grade 2 CTCAE v 3.0 Arm 1 (Levonorgestrel)	0
Grade 3 CTCAE v 3.0 Arm 1 (Levonorgestrel)	0
Grade 4 CTCAE v3.0 Arm 1 Levonorgestrel)	0
Grade 5 CTCAE v3.0 Arm I (Levonorgestrel)	0
Grade 1 CTCAE 3.0 Arm II (Placebo)	0
Grade 2 CTCAE 3.0 Arm II (Placebo)	0
Grade 3 CTCAE 3.0 Arm II (Placebo)	0
Grade 4 CTCAE 3.0 Arm II (Placebo)	0
Grade 5 CTCAE 3.0 Arm II (Placebo)	0

Dermatology/Skin

Group	Value	95% CI
Grade 1 CTCAE v 3.0 Arm I (Levonorgestrel)	2
Grade 2 CTCAE v 3.0 Arm 1 (Levonorgestrel)	0
Grade 3 CTCAE v 3.0 Arm 1 (Levonorgestrel)	0
Grade 4 CTCAE v3.0 Arm 1 Levonorgestrel)	0
Grade 5 CTCAE v3.0 Arm I (Levonorgestrel)	0
Grade 1 CTCAE 3.0 Arm II (Placebo)	1
Grade 2 CTCAE 3.0 Arm II (Placebo)	0
Grade 3 CTCAE 3.0 Arm II (Placebo)	0
Grade 4 CTCAE 3.0 Arm II (Placebo)	0
Grade 5 CTCAE 3.0 Arm II (Placebo)	0

Endocrine

Group	Value	95% CI
Grade 1 CTCAE v 3.0 Arm I (Levonorgestrel)	1
Grade 2 CTCAE v 3.0 Arm 1 (Levonorgestrel)	0
Grade 3 CTCAE v 3.0 Arm 1 (Levonorgestrel)	0
Grade 4 CTCAE v3.0 Arm 1 Levonorgestrel)	0
Grade 5 CTCAE v3.0 Arm I (Levonorgestrel)	0
Grade 1 CTCAE 3.0 Arm II (Placebo)	2
Grade 2 CTCAE 3.0 Arm II (Placebo)	1
Grade 3 CTCAE 3.0 Arm II (Placebo)	0
Grade 4 CTCAE 3.0 Arm II (Placebo)	0
Grade 5 CTCAE 3.0 Arm II (Placebo)	0

Gastrointestinal

Group	Value	95% CI
Grade 1 CTCAE v 3.0 Arm I (Levonorgestrel)	1
Grade 2 CTCAE v 3.0 Arm 1 (Levonorgestrel)	0
Grade 3 CTCAE v 3.0 Arm 1 (Levonorgestrel)	0
Grade 4 CTCAE v3.0 Arm 1 Levonorgestrel)	0
Grade 5 CTCAE v3.0 Arm I (Levonorgestrel)	0
Grade 1 CTCAE 3.0 Arm II (Placebo)	0
Grade 2 CTCAE 3.0 Arm II (Placebo)	1
Grade 3 CTCAE 3.0 Arm II (Placebo)	0
Grade 4 CTCAE 3.0 Arm II (Placebo)	0
Grade 5 CTCAE 3.0 Arm II (Placebo)	0

Renal/Genitourinary

Group	Value	95% CI
Grade 1 CTCAE v 3.0 Arm I (Levonorgestrel)	2
Grade 2 CTCAE v 3.0 Arm 1 (Levonorgestrel)	0
Grade 3 CTCAE v 3.0 Arm 1 (Levonorgestrel)	0
Grade 4 CTCAE v3.0 Arm 1 Levonorgestrel)	0
Grade 5 CTCAE v3.0 Arm I (Levonorgestrel)	0
Grade 1 CTCAE 3.0 Arm II (Placebo)	0
Grade 2 CTCAE 3.0 Arm II (Placebo)	0
Grade 3 CTCAE 3.0 Arm II (Placebo)	0
Grade 4 CTCAE 3.0 Arm II (Placebo)	0
Grade 5 CTCAE 3.0 Arm II (Placebo)	0

Hemorrhage/Bleeding

Group	Value	95% CI
Grade 1 CTCAE v 3.0 Arm I (Levonorgestrel)	3
Grade 2 CTCAE v 3.0 Arm 1 (Levonorgestrel)	0
Grade 3 CTCAE v 3.0 Arm 1 (Levonorgestrel)	0
Grade 4 CTCAE v3.0 Arm 1 Levonorgestrel)	0
Grade 5 CTCAE v3.0 Arm I (Levonorgestrel)	0
Grade 1 CTCAE 3.0 Arm II (Placebo)	1
Grade 2 CTCAE 3.0 Arm II (Placebo)	0
Grade 3 CTCAE 3.0 Arm II (Placebo)	0
Grade 4 CTCAE 3.0 Arm II (Placebo)	0
Grade 5 CTCAE 3.0 Arm II (Placebo)	0

Proportion of Proliferation as Measured by Ki-67 Secondary · Time of surgery (4 to 6 weeks after entry)

Group	Value	95% CI
Arm I (Levenorgestrel)	.003	0 – .008
Arm II (Placebo)	.008	.002 – .028

Patients With High Expression of Transforming Growth Factor-beta 1 Secondary · Baseline to time of surgery (4 to 6 weeks)

Group	Value	95% CI
Arm I (Levenorgestrel)	6
Arm II (Placebo)	3

Median Proportion Cells That Are Apoptotic in Fallopian Tube Tissue Secondary · Surgical specimen (4-6 weeks after entry)

The median proportion of cells that are considered to be apoptotic are counted in the fallopian tube tissue sample, among the total number of cells available in the sample slide

Group	Value	95% CI
Arm I (Levenorgestrel)	.205	.07 – .395
Arm II (Placebo)	.079	.01 – .25

Adverse events — posted to ClinicalTrials.gov

Time frame: Study Treatment - 4 - 6 weeks from enrollment. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm I (Levenorgestrel)

Serious: 0/33 (0%)

Deaths: —

Arm II (Placebo)

Serious: 0/31 (0%)

Deaths: —

Other adverse events (35 terms — click to expand)

Reaction	System	Arm I (Levenorgestrel)	Arm II (Placebo)
Hemoglobin	Blood and lymphatic system disorders	—	—
Hemorrhage, Gu - Vagina	Vascular disorders	—	—
Leukocytes	Blood and lymphatic system disorders	—	—
Acne	Skin and subcutaneous tissue disorders	—	—
Hot Flashes	Endocrine disorders	—	—
Pain: Head/Headache	General disorders	—	—
Vaginal Discharge	Reproductive system and breast disorders	—	—
Allergy/Immunology - Other	Immune system disorders	—	—
Rhinitis	Immune system disorders	—	—
Neutrophils	Blood and lymphatic system disorders	—	—
Blood/Bone Marrow - Other	Blood and lymphatic system disorders	—	—
Hypertension	Cardiac disorders	—	—
Sweating	General disorders	—	—
Fever	General disorders	—	—
Dermatology/Skin - Other	Skin and subcutaneous tissue disorders	—	—
Hyperthyroidism	Endocrine disorders	—	—
Flatulence	Gastrointestinal disorders	—	—
Distention	Gastrointestinal disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Infection - Other	Infections and infestations	—	—
Inf Unknown Anc: Bronchus	Infections and infestations	—	—
Inf Unknown Anc: Urinary Tract Nos	Infections and infestations	—	—
Inf Unknown Anc: Colon	Infections and infestations	—	—
Hypocalcemia	Metabolism and nutrition disorders	—	—
Hyperglycemia	Metabolism and nutrition disorders	—	—
Hypokalemia	Metabolism and nutrition disorders	—	—
Dizziness	Nervous system disorders	—	—
Pain: Chest /Thorax Nos	General disorders	—	—
Pain: Back	General disorders	—	—
Pain: Bladder	General disorders	—	—
Pain: Abdominal Pain Nos	General disorders	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—
Urinary Retention	Renal and urinary disorders	—	—
Urinary Frequency	Renal and urinary disorders	—	—
Sexual/Reproductive Function: Other	Reproductive system and breast disorders	—	—

Data from ClinicalTrials.gov NCT00445887 adverse events section.

Sponsor's own description

This randomized phase II trial is studying how well levonorgestrel works in preventing ovarian cancer in patients at high risk for ovarian cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of levonorgestrel may prevent ovarian cancer.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Hormone response in ovarian cancer: time to reconsider as a clinical target?
Modugno F, Laskey R, Smith AL, Andersen CL, et al · · 2012 · cited 107× · PMID 23045324 · DOI 10.1530/erc-12-0175
Lessons from the Failure to Complete a Trial of Denosumab in Women With a Pathogenic BRCA1/2 Variant Scheduling Risk-Reducing Salpingo-Oophorectomy.
Trivedi MS, Arber N, Friedman E, Garber JE, et al · · 2022 · cited 4× · PMID 36001346 · DOI 10.1158/1940-6207.capr-22-0051
IDEA: Integrated Drug Expression Analysis-Integration of Gene Expression and Clinical Data for the Identification of Therapeutic Candidates.
Ung MH, Varn FS, Cheng C. · · 2015 · cited 3× · PMID 26312165 · DOI 10.1002/psp4.51

Verify or expand the search:

Other trials of Laboratory Biomarker Analysis

Trials testing the same drug.

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NCT05396859 — Entrectinib in Combination With ASTX727 for the Treatment of Relapsed/Refractory TP53 Mutated Acute Myeloid Leukemia · Phase 1 · active not recruiting

Other recruiting trials for Ovarian Carcinoma

Currently open trials in the same condition.

NCT07282158 — Adapted Helping Ovarian Cancer Patients Cope Intervention to Address Burnout for Gynecologic Oncology Clinicians · NA · recruiting
NCT07280312 — Ultrasound Microvessel Imaging for the Evaluation of Ovarian and Adnexal Lesions · NA · recruiting
NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr · Phase 2 · recruiting
NCT06964009 — DT2216 + Paclitaxel in Platinum-Resistant Ovarian Cancer · Phase 1 · recruiting
NCT07118176 — Determining the Biodistribution of an Imaging Tracer (68Ga-FAPi-46) in Patients With Solid Tumors or Hematologic Cancers · Phase 1 · recruiting

Other Gynecologic Oncology Group trials

Trials by the same sponsor.

NCT04393285 — Abemaciclib and Letrozole to Treat Endometrial Cancer · Phase 2 · active not recruiting
NCT03673124 — Ribociclib and Letrozole Treatment in Ovarian Cancer · Phase 2 · active not recruiting
NCT02065687 — Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent · Phase 2, PHASE3 · unknown
NCT01720173 — Dalantercept in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer · Phase 2 · completed
NCT01406769 — Bioimpedance Spectroscopy in Detecting Lower-Extremity Lymphedema in Patients With Stage I, Stage II, Stage III, or Stag · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00445887 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gynecologic Oncology Group
Last refreshed: 19 November 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00445887.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing