Trial · NCT00001259

A Treatment Study for Premenstrual Syndrome (PMS)

NCT00001259, Phase 1, Completed, National Institute of Mental Health (NIMH); results first posted 2023-03-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Treatment Study for Premenstrual Syndrome (PMS). Trials, record NCT00001259. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00001259

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Trial

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

Title: A Treatment Study for Premenstrual Syndrome (PMS)
NCT number: NCT00001259
Status: Completed
Phases: Phase 1
Enrollment: 60 participants, actual
Lead sponsor: National Institute of Mental Health (NIMH)
Conditions: Premenstrual Syndrome, Menstruation Disturbances
Interventions: Leuprolide, Estradiol Patches, Progesterone, Placebo patch, Placebo injection, Placebo suppository
First posted: 1999-11-04
Last updated: 2023-03-02
Results first posted: 2023-03-02

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Mean Beck Depression Inventory Score	Placebo: Weeks 6 and 8 of Placebo; Lupron only: Weeks 6 and 8 or 10 and 12; Estradiol or progesterone: Weeks 2 and 4	The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures the severity of symptoms accompanying depression. Each item has a minimum score of 0 and a maximum score of 3, with higher numbers consistent with more severe symptoms. The score of each item is summed to amount the overall BDI score, with a minimum score of 0 and a maximum score of 63. Higher BDI scores are consistent with more severe depression. Score of 16 or greater is consistent with clinical depression. Each participant completed the BDI every 2 weeks during each of the study phases throughout the 6-month study. Outcome measures reported consist of the average of two BDI scores from each phase of the study: the last 4 weeks of the GnRH agonist alone; weeks 6 and 8 of placebo alone; during the 4-week long estradiol phase (weeks 2 and 4 of estradiol) and the 4-week long progesterone phase (weeks 2 and 4 of progesterone).

Source ClinicalTrials.gov

Outcomes1

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Beck Depression Inventory Score	Placebo: Weeks 6 and 8 of Placebo; Lupron only: Weeks 6 and 8 or 10 and 12; Estradiol or progesterone: Weeks 2 and 4	Analyses included comparison of participants mean BDI scores during each phase of the study	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Spread	Units
Mean Beck Depression Inventory Score	Placebo	2.6	Standard Deviation 2.6	score on a scale
Mean Beck Depression Inventory Score	GnRH Agonist Injections (Lupron-L Only)	3.0	Standard Deviation 3.8	score on a scale
Mean Beck Depression Inventory Score	Estradiol	5.3	Standard Deviation 5.3	score on a scale
Mean Beck Depression Inventory Score	Progesterone	3.6	Standard Deviation 5.7	score on a scale

Source ClinicalTrials.gov

Participant flow112

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

Period	Milestone	Group	Participants
Study 1	STARTED	Study 1, Phase 1, Assignment 1 - Placebo	10
Study 1	STARTED	Study 1, Phase 1, Assignment 2 - GnRH Agonist Injections (Lupron-L Only)	10
Study 1	STARTED	Study 1, Phase 2, Arm 1 - Estradiol, Then Progesterone	0
Study 1	STARTED	Study 1, Phase 2, Arm 2 - Progesterone, Then Estradiol	0
Study 1	STARTED	Study 2, Phase 1 - GnRH Agonist Injections (Lupron-L Only)	0
Study 1	STARTED	Study 2, Phase 2, Arm 1 - Estradiol, Then Progesterone	0
Study 1	STARTED	Study 2, Phase 2, Arm 2 - Progesterone, Then Estradiol	0
Study 1	Completed Phase 1	Study 1, Phase 1, Assignment 1 - Placebo	10
Study 1	Completed Phase 1	Study 1, Phase 1, Assignment 2 - GnRH Agonist Injections (Lupron-L Only)	10
Study 1	Completed Phase 1	Study 1, Phase 2, Arm 1 - Estradiol, Then Progesterone	0

1 to 10 of 112Source ClinicalTrials.gov

See all 112 participant flow

Adverse events24

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Pain	General disorders	Placebo	0	10	0
other	Pain	General disorders	GnRH Agonist Injections (Lupron-L Only)	0	58	0
other	Pain	General disorders	Estradiol	2	48	2
other	Pain	General disorders	Progesterone	0	48	0
other	Paraesthesia	Nervous system disorders	Placebo	0	10	0
other	Paraesthesia	Nervous system disorders	GnRH Agonist Injections (Lupron-L Only)	1	58	1
other	Paraesthesia	Nervous system disorders	Estradiol	0	48	0
other	Paraesthesia	Nervous system disorders	Progesterone	0	48	0
other	Fluid retention	Metabolism and nutrition disorders	Placebo	0	10	0
other	Fluid retention	Metabolism and nutrition disorders	GnRH Agonist Injections (Lupron-L Only)	1	58	1

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	10
Total, all-cause mortality	GnRH Agonist Injections (Lupron-L Only)	0	58
Total, all-cause mortality	Estradiol	0	48
Total, all-cause mortality	Progesterone	0	48
Total, other adverse events	Placebo	0	10
Total, other adverse events	GnRH Agonist Injections (Lupron-L Only)	2	58
Total, other adverse events	Estradiol	3	48
Total, other adverse events	Progesterone	0	48
Total, serious adverse events	Placebo	0	10
Total, serious adverse events	GnRH Agonist Injections (Lupron-L Only)	0	58

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
2011161	BACKGROUND	PubMed
2962499	BACKGROUND	PubMed
9435325	BACKGROUND	PubMed
28044059	DERIVED	PubMed
28786978	DERIVED	PubMed
30184299	DERIVED	PubMed
34035477	DERIVED	PubMed

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/NCT00001259

GET https://conductscience.org/api/trials/v1/NCT00001259/flow?page=2

API reference For AI assistants