AtrophyPhase 3NCT01585558

Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus

A Phase 3 study testing Ospemifene (Dose 1) and Ospemifene (Dose 2) in people with Atrophy and Vaginal Diseases, run by Shionogi.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The primary objective of the study was to assess the long-term safety of 30- and 60-mg daily doses of ospemifene in the treatment of Vulvar and Vaginal Atrophy (VVA) in postmenopausal women with an intact uterus. Read more about this study

Who is it for?: Ages 40 to 80 years, women only
Conditions the study is for: Atrophy, Vaginal Diseases
What is being tested?: Ospemifene (Dose 1) and Ospemifene (Dose 2)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 180 participants
Where: No sites listed yet
Study dates: 16 May 2006to 18 Sep 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 80 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Postmenopausal women aged 40 to 80 years with a diagnosis of vulvar and vaginal atrophy (VVA) as assessed by vaginal pH, maturation index of vaginal smear, and self-reported symptoms at Baseline for Protocol 15-50310
Had an intact uterus
Met the inclusion and exclusion criteria for Protocol 15-50310
Had completed Protocol 15-50310

Who cannot join

Had clinically significant abnormal findings at the Week 12 End of Study visit for Protocol 15-50310
Had any physical or mental condition which, in the opinion of the investigator, may have interfered with the subject's ability to comply with the study procedures

About this study

Official title: Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus: A 40 Week Randomized, Double Blind, Placebo Controlled, Follow-Up to Protocol 15-50310.

Conditions: Atrophy, Vaginal Diseases
Being tested: Ospemifene (Dose 1), Ospemifene (Dose 2), Placebo
Keywords: Menopausal symptoms, Urogenital atrophy, Vulvar and vaginal atrophy in menopausal women, Vaginal atrophy
Medical subject headings: Atrophy, Vaginal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ospemifene (Dose 1)Drug
Ospemifene (Dose 2)Drug
PlaceboDrug

Study groups in NCT01585558
Study group	Role	What they receive
Treatment Group 1	Experimental	Not described Receives: Drug: Ospemifene (Dose 1)
Treatment Group 2	Experimental	Not described Receives: Drug: Ospemifene (Dose 2)
Treatment Group 3	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Adverse Events (AEs)
Measured: Week 20 (Phone Contact) to Week 56 (Visit 7)
Assessment of Cervical Pap Smear Samples
Cervical Pap smear samples were used to evaluate: atypical squamous cells of undetermined significance (ASC-US), squamous intraepithelial lesions (SILs), intraepithelial lesions or malignancy, and reactive endocervical cells and/or metaplastic cells.
Measured: Week 52 (Visit 6)
Assessment of Endometrial Biopsy
Assessments were based on Blaustein's classification.
Measured: Week 52 (Visit 6)
Mean Percent Change From Baseline in Serum Lipids
Measured: Baseline to Week 26 (Visit 5)
Mean Percent Change From Baseline in Serum Lipids
Measured: Baseline to Week 52 (Visit 6)
Mean Change in Blood Chemistry Parameters
Measured: Baseline to Week 26 (Visit 5)
Mean Change in Blood Chemistry Parameters
Measured: Baseline to Week 52 (Visit 6)
Assessment of Endometrial Safety With a Transvaginal Ultrasound (TVU)
Mean change in endometrial thickness from baseline
Measured: Baseline to Week 26 (Visit 5)
Assessment of Endometrial Safety With a TVU
Mean change in endometrial thickness from baseline
Measured: Baseline to Week 52 (Visit 6)
Change From Baseline in Visual Evaluation of the Vagina
Petechiae, pallor, friability, dryness in the mucosa, and redness in the mucosa were assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe).
Measured: Baseline to Week 26 (Visit 5)
Change From Baseline in Visual Evaluation of the Vagina
Petechiae, pallor, friability, dryness in the mucosa, and redness in the mucosa were assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe).
Measured: Baseline to Week 52 (Visit 6)
Change From Baseline in Estradiol (E2) Levels
Measured: Baseline to Week 26 (Visit 5)
Change From Baseline in Luteinizing Hormone (LH) Levels
Measured: Baseline to Week 26 (Visit 5)
Change From Baseline in Follicle Stimulating Hormone (FSH) Levels
Measured: Baseline to Week 26 (Visit 5)
Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels
Measured: Baseline to Week 26 (Visit 5)
Change From Baseline in Testosterone (Total) Levels
Measured: Baseline to Week 26 (Visit 5)
Change From Baseline in Testosterone (Free) Levels
Measured: Baseline to Week 26 (Visit 5)
Change From Baseline in E2 Levels
Measured: Baseline to Week 52 (Visit 6)
Change From Baseline in LH Levels
Measured: Baseline to Week 52 (Visit 6)
Change From Baseline in FSH Levels
Measured: Baseline to Week 52 (Visit 6)
Change From Baseline in SHBG Levels
Measured: Baseline to Week 52 (Visit 6)
Assessment of Mammography
Mammography was done for the detection of characteristic masses and microcalcifications in the breast.
Measured: Week 52 (Visit 6)
Change From Baseline in Testosterone (Total) Levels
Measured: Baseline to Week 52 (Visit 6)
Change From Baseline in Testosterone (Free) Levels
Measured: Baseline to Week 52 (Visit 6)
Change From Baseline in Antithrombin Antigen, P Levels
Measured: Baseline to Week 26 (Visit 5)
Change From Baseline in Fibrinogen Levels
Measured: Baseline to Week 26 (Visit 5)
Change From Baseline in Protein C Ag, P Levels
Measured: Baseline to Week 26 (Visit 5)
Change From Baseline in Protein S Ag (Free), P Levels
Measured: Baseline to Week 26 (Visit 5)
Change From Baseline in Thromboplastin Time
Measured: Baseline to Week 26 (Visit 5)
Change From Baseline in Antithrombin Antigen, P Levels
Measured: Baseline to Week 52 (Visit 6)
Change From Baseline in Fibrinogen Levels
Measured: Baseline to Week 52 (Visit 6)
Change From Baseline in Protein C Ag, P Levels
Measured: Baseline to Week 52 (Visit 6)
Change From Baseline in Protein S Ag (Free), P Levels
Measured: Baseline to Week 52 (Visit 6)
Change From Baseline in Thromboplastin Time
Measured: Baseline to Week 52 (Visit 6)
Assessment of Breast Palpation
Breast palpation was done by the investigator to assess abnormalities in the breast.
Measured: Week 26 (Visit 5)
Assessment of Breast Palpation
Breast palpation was done by the investigator to assess abnormalities in the breast.
Measured: Week 52 (Visit 6)
Assessment of Hematology Tests
Change from baseline
Measured: Baseline to Week 26 (Visit 5)
Change From Baseline in Erythrocyte (RBC) Levels
Measured: Baseline to Week 26 (Visit 5)
Change From Baseline in Hemogobin Levels
Measured: Baseline to Week 26 (Visit 5)
Change From Baseline in Hematocrit Levels
Measured: Baseline to Week 26 (Visit 5)
Assessment of Hematology Test Values
Change from baseline
Measured: Baseline to Week 52 (Visit 6)
Change From Baseline in Erythrocyte (RBC) Levels
Measured: Baseline to Week 52 (Visit 6)
Change From Baseline in Hemoglobin Levels
Measured: Baseine to Week 52 (Visit 6)
Change From Baseline in Hematocrit Levels
Measured: Baseline to Week 52 (Visit 6)
Change From Baseline in pH of Urine
Measured: Baseline to Week 26 (Visit 5)
Change From Baseline in Specific Gravtiy of Urine
Measured: Baseline to Week 26 (Visit 5)
Change From Baseline in pH of Urine
Measured: Baseline to Week 52 (Visit 6)
Change From Baseline in Specific Gravity of Urine
Measured: Baseline to Week 52 (Visit 6)
Change From Baseline in Systolic Blood Pressure (SBP)
Measured: Baseline to Week 26 (Visit 5)
Change From Baseline in Diastolic Blood Pressure (DBP)
Measured: Baseline to Week 26 (Visit 5)
Change From Baseline in Pulse Rate
Measured: Baseline to Week 26 (Visit 5)
Change From Baseline in Weight
Measured: Baseline to Week 26 (Visit 5)
Change From Baseline in BMI
Measured: Baseline to Week 26
Change From Baseline in SBP
Measured: Baseline to Week 52 (Visit 6)
Change From Baseline in DBP
Measured: Baseline to Week 52 (Visit 6)
Change From Baseline in Pulse Rate
Measured: Baseline to Week 52 (Visit 6)
Change From Baseline in Weight
Measured: Baseline to Week 52 (Visit 6)
Change From Baseline in BMI
Measured: Baseline to Week 52 (Visit 6)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 May 200618 Sep 2008

First posted26 Apr 2012 (estimated)
Study start16 May 2006
Primary completion19 Aug 2008
Study completion18 Sep 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AtrophyStudies of the same condition, open and under way.
More trials run by ShionogiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01585558
Sponsor's protocol ID: 15-50310X
Status last verified: Apr 2018
First submitted: 18 Apr 2012
Last updated: 21 May 2018
Results posted: Yes, on ClinicalTrials.gov

Publications

Lara LA, Cartagena-Ramos D, Figueiredo JB, Rosa-E-Silva ACJ, Ferriani RA, Martins WP, Fuentealba-Torres M. Hormone therapy for sexual function in perimenopausal and postmenopausal women. Cochrane Database Syst Rev. 2023 Aug 24;8(8):CD009672. doi: 10.1002/14651858.CD009672.pub3.
PubMed 37619252

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Atrophy trials

Study at a glance

From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus: A 40 Week Randomized, Double Blind, Placebo Controlled, Follow-Up to Protocol 15-50310.
ClinicalTrials.gov ID: NCT01585558
Acronym / sponsor ID: 15-50310X
Conditions: Atrophy, Vaginal Diseases
Keywords: Menopausal symptoms, Urogenital atrophy, Vulvar and vaginal atrophy in menopausal women, Vaginal atrophy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: ShionogiIndustry (pharma, biotech, devices)
Collaborators: QuatRx Pharmaceuticals
Study start: 16 May 2006 (actual)
Primary completion: 19 Aug 2008 (actual)
Study completion: 18 Sep 2008 (actual)
First posted: 26 Apr 2012 (estimated)
Results: Posted 28 Jun 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Treatment Group 1	Experimental	Drug: Ospemifene (Dose 1)
Treatment Group 2	Experimental	Drug: Ospemifene (Dose 2)
Treatment Group 3	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 40 to 80 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Postmenopausal women aged 40 to 80 years with a diagnosis of vulvar and vaginal atrophy (VVA) as assessed by vaginal pH, maturation index of vaginal smear, and self-reported symptoms at Baseline for Protocol 15-50310
Had an intact uterus
Met the inclusion and exclusion criteria for Protocol 15-50310
Had completed Protocol 15-50310

Key exclusion criteria (2 listed)

Had clinically significant abnormal findings at the Week 12 End of Study visit for Protocol 15-50310
Had any physical or mental condition which, in the opinion of the investigator, may have interfered with the subject's ability to comply with the study procedures

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ospemifene (Dose 1)	Drug	Treatment Group 1
Ospemifene (Dose 2)	Drug	Treatment Group 2
Placebo	Drug	Treatment Group 3

Primary outcome

Incidence of Adverse Events (AEs)
Time frame: Week 20 (Phone Contact) to Week 56 (Visit 7)
Assessment of Cervical Pap Smear Samples
Time frame: Week 52 (Visit 6)
Cervical Pap smear samples were used to evaluate: atypical squamous cells of undetermined significance (ASC-US), squamous intraepithelial lesions (SILs), intraepithelial lesions or malignancy, and reactive endocervical cells and/or metaplastic cells.
Assessment of Endometrial Biopsy
Time frame: Week 52 (Visit 6)
Assessments were based on Blaustein's classification.
Mean Percent Change From Baseline in Serum Lipids
Time frame: Baseline to Week 26 (Visit 5)
Mean Percent Change From Baseline in Serum Lipids
Time frame: Baseline to Week 52 (Visit 6)
Mean Change in Blood Chemistry Parameters
Time frame: Baseline to Week 26 (Visit 5)
Mean Change in Blood Chemistry Parameters
Time frame: Baseline to Week 52 (Visit 6)
Assessment of Endometrial Safety With a Transvaginal Ultrasound (TVU)
Time frame: Baseline to Week 26 (Visit 5)
Mean change in endometrial thickness from baseline
Assessment of Endometrial Safety With a TVU
Time frame: Baseline to Week 52 (Visit 6)
Mean change in endometrial thickness from baseline
Change From Baseline in Visual Evaluation of the Vagina
Time frame: Baseline to Week 26 (Visit 5)
Petechiae, pallor, friability, dryness in the mucosa, and redness in the mucosa were assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe).
Change From Baseline in Visual Evaluation of the Vagina
Time frame: Baseline to Week 52 (Visit 6)
Petechiae, pallor, friability, dryness in the mucosa, and redness in the mucosa were assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe).
Change From Baseline in Estradiol (E2) Levels
Time frame: Baseline to Week 26 (Visit 5)
Change From Baseline in Luteinizing Hormone (LH) Levels
Time frame: Baseline to Week 26 (Visit 5)
Change From Baseline in Follicle Stimulating Hormone (FSH) Levels
Time frame: Baseline to Week 26 (Visit 5)
Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels
Time frame: Baseline to Week 26 (Visit 5)
Change From Baseline in Testosterone (Total) Levels
Time frame: Baseline to Week 26 (Visit 5)
Change From Baseline in Testosterone (Free) Levels
Time frame: Baseline to Week 26 (Visit 5)
Change From Baseline in E2 Levels
Time frame: Baseline to Week 52 (Visit 6)
Change From Baseline in LH Levels
Time frame: Baseline to Week 52 (Visit 6)
Change From Baseline in FSH Levels
Time frame: Baseline to Week 52 (Visit 6)
Change From Baseline in SHBG Levels
Time frame: Baseline to Week 52 (Visit 6)
Assessment of Mammography
Time frame: Week 52 (Visit 6)
Mammography was done for the detection of characteristic masses and microcalcifications in the breast.
Change From Baseline in Testosterone (Total) Levels
Time frame: Baseline to Week 52 (Visit 6)
Change From Baseline in Testosterone (Free) Levels
Time frame: Baseline to Week 52 (Visit 6)
Change From Baseline in Antithrombin Antigen, P Levels
Time frame: Baseline to Week 26 (Visit 5)
Change From Baseline in Fibrinogen Levels
Time frame: Baseline to Week 26 (Visit 5)
Change From Baseline in Protein C Ag, P Levels
Time frame: Baseline to Week 26 (Visit 5)
Change From Baseline in Protein S Ag (Free), P Levels
Time frame: Baseline to Week 26 (Visit 5)
Change From Baseline in Thromboplastin Time
Time frame: Baseline to Week 26 (Visit 5)
Change From Baseline in Antithrombin Antigen, P Levels
Time frame: Baseline to Week 52 (Visit 6)
Change From Baseline in Fibrinogen Levels
Time frame: Baseline to Week 52 (Visit 6)
Change From Baseline in Protein C Ag, P Levels
Time frame: Baseline to Week 52 (Visit 6)
Change From Baseline in Protein S Ag (Free), P Levels
Time frame: Baseline to Week 52 (Visit 6)
Change From Baseline in Thromboplastin Time
Time frame: Baseline to Week 52 (Visit 6)
Assessment of Breast Palpation
Time frame: Week 26 (Visit 5)
Breast palpation was done by the investigator to assess abnormalities in the breast.
Assessment of Breast Palpation
Time frame: Week 52 (Visit 6)
Breast palpation was done by the investigator to assess abnormalities in the breast.
Assessment of Hematology Tests
Time frame: Baseline to Week 26 (Visit 5)
Change from baseline
Change From Baseline in Erythrocyte (RBC) Levels
Time frame: Baseline to Week 26 (Visit 5)
Change From Baseline in Hemogobin Levels
Time frame: Baseline to Week 26 (Visit 5)
Change From Baseline in Hematocrit Levels
Time frame: Baseline to Week 26 (Visit 5)
Assessment of Hematology Test Values
Time frame: Baseline to Week 52 (Visit 6)
Change from baseline
Change From Baseline in Erythrocyte (RBC) Levels
Time frame: Baseline to Week 52 (Visit 6)
Change From Baseline in Hemoglobin Levels
Time frame: Baseine to Week 52 (Visit 6)
Change From Baseline in Hematocrit Levels
Time frame: Baseline to Week 52 (Visit 6)
Change From Baseline in pH of Urine
Time frame: Baseline to Week 26 (Visit 5)
Change From Baseline in Specific Gravtiy of Urine
Time frame: Baseline to Week 26 (Visit 5)
Change From Baseline in pH of Urine
Time frame: Baseline to Week 52 (Visit 6)
Change From Baseline in Specific Gravity of Urine
Time frame: Baseline to Week 52 (Visit 6)
Change From Baseline in Systolic Blood Pressure (SBP)
Time frame: Baseline to Week 26 (Visit 5)
Change From Baseline in Diastolic Blood Pressure (DBP)
Time frame: Baseline to Week 26 (Visit 5)
Change From Baseline in Pulse Rate
Time frame: Baseline to Week 26 (Visit 5)
Change From Baseline in Weight
Time frame: Baseline to Week 26 (Visit 5)
Change From Baseline in BMI
Time frame: Baseline to Week 26
Change From Baseline in SBP
Time frame: Baseline to Week 52 (Visit 6)
Change From Baseline in DBP
Time frame: Baseline to Week 52 (Visit 6)
Change From Baseline in Pulse Rate
Time frame: Baseline to Week 52 (Visit 6)
Change From Baseline in Weight
Time frame: Baseline to Week 52 (Visit 6)
Change From Baseline in BMI
Time frame: Baseline to Week 52 (Visit 6)

Results and safety

Results posted to the registry on 28 Jun 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ospemifene 30 mg (Dose 1)	62	49
Ospemifene 60 mg (Dose 2)	69	57
Placebo	49	34

Primary outcome: Incidence of Adverse Events (AEs)

Time frame: Week 20 (Phone Contact) to Week 56 (Visit 7). Number. Unit: Participants

Measure	Ospemifene 30 mg (Dose 1) n = 62	Ospemifene 60 mg (Dose 2) n = 69	Placebo n = 49
Treatment-Emergent AE	38	44	22
Related AE (Possibly/Probably/Definitely Related)	11	18	5
AE Causing Study Drug Discontinuation	3	4	1
Serious AE	2	5	1
Severe AE	6	7	2

Primary outcome: Assessment of Cervical Pap Smear Samples

Time frame: Week 52 (Visit 6). Number. Unit: Participants

Measure	Ospemifene 30 mg (Dose 1) n = 49	Ospemifene 60 mg (Dose 2) n = 58	Placebo n = 34
ASC-US	1	2	0
Inadequate squamous epithelial component	1	0	1
Low grade SIL (slight dysplasia and/or HPV effect)	0	1	0
Negative for intraepithelial lesion or malignancy	45	54	33
Reactive endocervical and/or metaplastic cells	1	1	0
Unsatisfactory: Due to reasons noted	1	0	0

Population analysed: The ITT population was used for the analysis. For this particular outcome measure, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 34 out of 49 subjects in the placebo group were analyzed.

Primary outcome: Assessment of Endometrial Biopsy

Time frame: Week 52 (Visit 6). Number. Unit: Participants

Measure	Ospemifene 30 mg (Dose 1) n = 46	Ospemifene 60 mg (Dose 2) n = 55	Placebo n = 32
Atrophic/inactive/insufficient	44	53	32
Weakly proliferative	1	1	0
Atypical epithelial proliferation	1	0	0
Proliferative pattern, disordered type	0	1	0
Other (Polyp, atrophic type)	0	0	0
Hyperplasia or carcinoma	0	0	0

Population analysed: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 46 out of 62 subjects in the ospemifene 30 mg group, 55 out of 69 subjects in the ospemifene 60 mg group, and 32 out of 49 subjects in the placebo group were analyzed.

Primary outcome: Mean Percent Change From Baseline in Serum Lipids

Time frame: Baseline to Week 26 (Visit 5). Mean (Standard Deviation). Unit: percent change

Measure	Ospemifene 30 mg (Dose 1) n = 62	Ospemifene 60 mg (Dose 2) n = 69	Placebo n = 49
Total Cholesterol	-0.14 (14.807)	2.35 (13.663)	6.24 (12.904)
Low-density-lipoprotein cholesterol (LDL-C)	-0.02 (19.462)	2.42 (19.107)	10.38 (19.776)
High-density-lipoprotein cholesterol (HDL-C)	6.48 (13.881)	5.76 (12.686)	2.39 (14.026)
Triglycerides	-0.66 (28.864)	5.12 (31.076)	20.36 (41.755)

Adverse events

Time frame: 40 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ospemifene 30 mg (Dose 1)	2 of 62 (3.2%)	9 of 62 (14.5%)	Not reported
Ospemifene 60 mg (Dose 2)	5 of 69 (7.2%)	21 of 69 (30.4%)	Not reported
Placebo	1 of 49 (2%)	11 of 49 (22.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37619252Lara LA, Cartagena-Ramos D, Figueiredo JB, Rosa-E-Silva ACJ, Ferriani RA, Martins WP, Fuentealba-Torres M. Hormone therapy for sexual function in perimenopausal and postmenopausal women. Cochrane Database Syst Rev. 2023 Aug 24;8(8):CD009672. doi: 10.1002/14651858.CD009672.pub3.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shionogi Clinical Trials Administrator Clinical Support Help Line study director

Shionogi

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ospemifene (Dose 1) and Ospemifene (Dose 2) in people with Atrophy and Vaginal Diseases, run by Shionogi.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (AEs) (time frame: Week 20 (Phone Contact) to Week 56 (Visit 7)). The study lists 58 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01585558, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2018.