Trial · NCT00511797

SH T00186 Phase II/ III Optimal Drospirenone (DRSP) Dose Finding and Placebo-controlled Comparative Study

NCT00511797, Phase 2, Phase 3, Completed, Bayer; results first posted 2010-10-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. SH T00186 Phase II/ III Optimal Drospirenone (DRSP) Dose Finding and Placebo-controlled Comparative Study. Trials, record NCT00511797. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00511797

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Trial

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

Title: SH T00186 Phase II/ III Optimal Drospirenone (DRSP) Dose Finding and Placebo-controlled Comparative Study
NCT number: NCT00511797
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 249 participants, actual
Lead sponsor: Bayer
Conditions: Dysmenorrhea
Interventions: SH T04740B, SH T00186DF, SH T04740F, Placebo
First posted: 2007-08-06
Last updated: 2017-01-26
Results first posted: 2010-10-04

Source ClinicalTrials.gov

Registered outcomes20

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in Total Dysmenorrheal Score at Final Evaluation	Baseline and up to 4 Cycles (28 days per cycle)	Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6. Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol (Prog Med 2005:25 (3):739-758) of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.)
Secondary	Change From Baseline in Total Dysmenorrheal Score at Cycle 1 up to Cycle 4	Baseline and up to 4 Cycles (28 days per cycle)	Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6.
Secondary	Number of Participants With Severity of Lower Abdominal Pain During Menstruation at Cycle 4	Cycle 4 (28 days per cycle)	Severity of lower abdominal pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Secondary	Number of Participants With Severity of Low Back Pain During Menstruation at Cycle 4	Cycle 4 (28 days per cycle)	Severity of low back pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Secondary	Number of Participants With Severity of Headache During Menstruation at Cycle 4	Cycle 4 (28 days per cycle)	Severity of headache during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Secondary	Number of Participants With Severity of Nausea or Vomiting During Menstruation at Cycle 4	Cycle 4 (28 days per cycle)	Severity of nausea or vomiting during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Secondary	Number of Participants With Total Pelvic Pain Score at Times Other Than During Menstruation at Cycle 4	Cycle 4 (28 days per cycle)	Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.
Secondary	Change From Baseline in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation at Cycle 4	From baseline up to Cycle 4 (28 days per cycle)	VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).
Secondary	Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation at Cycle 4	Cycle 4 (28 days per cycle)	VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).
Secondary	Change From Baseline in Endometrial Thickness After 4-cycle Treatment	From baseline to Cycle 4 (28 days per cycle)	Endometrial thickness was measured via transvaginal ultrasound examination. The endometrium is the inner membrane of the uterus. During the menstrual cycle, the endometrium grows to a thick, blood vessel-rich, glandular tissue layer.

1 to 10 of 20Source ClinicalTrials.gov

See all 20 registered outcomes

Outcomes24

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Total Dysmenorrheal Score at Final Evaluation	Baseline and up to 4 Cycles (28 days per cycle)	FAS	scores on a scale	MEAN
SECONDARY	Change From Baseline in Total Dysmenorrheal Score at Cycle 1 up to Cycle 4	Baseline and up to 4 Cycles (28 days per cycle)	FAS	scores on a scale	MEAN
SECONDARY	Number of Participants With Severity of Lower Abdominal Pain During Menstruation at Cycle 4	Cycle 4 (28 days per cycle)	FAS (Participants with data at Cycle 4)	participants	NUMBER
SECONDARY	Number of Participants With Severity of Low Back Pain During Menstruation at Cycle 4	Cycle 4 (28 days per cycle)	FAS (Participants with data at Cycle 4)	participants	NUMBER
SECONDARY	Number of Participants With Severity of Headache During Menstruation at Cycle 4	Cycle 4 (28 days per cycle)	FAS (Participants with data at Cycle 4)	participants	NUMBER
SECONDARY	Number of Participants With Severity of Nausea or Vomiting During Menstruation at Cycle 4	Cycle 4 (28 days per cycle)	FAS (Participants with data at Cycle 4)	participants	NUMBER
SECONDARY	Number of Participants With Total Pelvic Pain Score at Times Other Than During Menstruation at Cycle 4	Cycle 4 (28 days per cycle)	FAS (Participants with data at Cycle 4)	participants	NUMBER
SECONDARY	Change From Baseline in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation at Cycle 4	From baseline up to Cycle 4 (28 days per cycle)	FAS (Participants with data at Cycle 4)	scores on a scale	MEAN
SECONDARY	Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation at Cycle 4	Cycle 4 (28 days per cycle)	FAS (Participants with data at Cycle 4)	scores on a scale	MEAN
SECONDARY	Change From Baseline in Endometrial Thickness After 4-cycle Treatment	From baseline to Cycle 4 (28 days per cycle)	FAS (Participants with data at Cycle 4)	mm	MEAN

1 to 10 of 24Source ClinicalTrials.gov

See all 24 outcomes

Results by group245

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

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Total Dysmenorrheal Score at Final Evaluation	DRSP 1 mg/EE 20 μg		-2.5	Standard Deviation 1.52	scores on a scale
Change From Baseline in Total Dysmenorrheal Score at Final Evaluation	DRSP 2 mg/EE 20 μg		-2.1	Standard Deviation 1.51	scores on a scale
Change From Baseline in Total Dysmenorrheal Score at Final Evaluation	DRSP 3 mg/EE 20 μg		-1.9	Standard Deviation 1.63	scores on a scale
Change From Baseline in Total Dysmenorrheal Score at Final Evaluation	Placebo		-1.0	Standard Deviation 1.53	scores on a scale
Change From Baseline in Total Dysmenorrheal Score at Cycle 1 up to Cycle 4	DRSP 1 mg/EE 20 μg	Cycle 1	-2.4	Standard Deviation 1.40	scores on a scale
Change From Baseline in Total Dysmenorrheal Score at Cycle 1 up to Cycle 4	DRSP 2 mg/EE 20 μg	Cycle 1	-2.1	Standard Deviation 1.49	scores on a scale
Change From Baseline in Total Dysmenorrheal Score at Cycle 1 up to Cycle 4	DRSP 3 mg/EE 20 μg	Cycle 1	-1.8	Standard Deviation 1.67	scores on a scale
Change From Baseline in Total Dysmenorrheal Score at Cycle 1 up to Cycle 4	Placebo	Cycle 1	-0.8	Standard Deviation 1.50	scores on a scale
Change From Baseline in Total Dysmenorrheal Score at Cycle 1 up to Cycle 4	DRSP 1 mg/EE 20 μg	Cycle 2	-2.1	Standard Deviation 1.40	scores on a scale
Change From Baseline in Total Dysmenorrheal Score at Cycle 1 up to Cycle 4	DRSP 2 mg/EE 20 μg	Cycle 2	-2.3	Standard Deviation 1.57	scores on a scale

1 to 10 of 245Source ClinicalTrials.gov

See all 245 results by group

Participant flow20

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

Period	Milestone	Group	Participants
Overall Study	STARTED	DRSP 1 mg/EE 20 μg	62
Overall Study	STARTED	DRSP 2 mg/EE 20 μg	63
Overall Study	STARTED	DRSP 3 mg/EE 20 μg	62
Overall Study	STARTED	Placebo	62
Overall Study	Subjects Dispensed Drugs	DRSP 1 mg/EE 20 μg	61
Overall Study	Subjects Dispensed Drugs	DRSP 2 mg/EE 20 μg	63
Overall Study	Subjects Dispensed Drugs	DRSP 3 mg/EE 20 μg	61
Overall Study	Subjects Dispensed Drugs	Placebo	59
Overall Study	Subjects Received Treatment	DRSP 1 mg/EE 20 μg	61
Overall Study	Subjects Received Treatment	DRSP 2 mg/EE 20 μg	62

1 to 10 of 20Source ClinicalTrials.gov

See all 20 participant flow

Adverse events92

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	Abdominal pain lower	Gastrointestinal disorders	DRSP 1 mg/EE 20 μg	5	62	5
other	Abdominal pain lower	Gastrointestinal disorders	DRSP 2 mg/EE 20 μg	7	63	10
other	Abdominal pain lower	Gastrointestinal disorders	DRSP 3 mg/EE 20 μg	9	62	10
other	Abdominal pain lower	Gastrointestinal disorders	Placebo	3	62	4
other	Abdominal pain upper	Gastrointestinal disorders	DRSP 1 mg/EE 20 μg	2	62	6
other	Abdominal pain upper	Gastrointestinal disorders	DRSP 2 mg/EE 20 μg	5	63	6
other	Abdominal pain upper	Gastrointestinal disorders	DRSP 3 mg/EE 20 μg	1	62	1
other	Abdominal pain upper	Gastrointestinal disorders	Placebo	1	62	1
other	Back pain	Musculoskeletal and connective tissue disorders	DRSP 1 mg/EE 20 μg	4	62	4
other	Back pain	Musculoskeletal and connective tissue disorders	DRSP 2 mg/EE 20 μg	8	63	10

1 to 10 of 92Source ClinicalTrials.gov

See all 92 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	DRSP 1 mg/EE 20 μg
Total, all-cause mortality	DRSP 2 mg/EE 20 μg
Total, all-cause mortality	DRSP 3 mg/EE 20 μg
Total, all-cause mortality	Placebo
Total, other adverse events	DRSP 1 mg/EE 20 μg	56	62
Total, other adverse events	DRSP 2 mg/EE 20 μg	58	63
Total, other adverse events	DRSP 3 mg/EE 20 μg	60	62
Total, other adverse events	Placebo	53	62
Total, serious adverse events	DRSP 1 mg/EE 20 μg	1	62
Total, serious adverse events	DRSP 2 mg/EE 20 μg	2	63

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37523477	DERIVED

Source 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/NCT00511797

GET https://conductscience.org/api/trials/v1/NCT00511797/outcomes?page=2

API reference For AI assistants